D-Laser Blue, D-Laser 16

• K Number: K210367
• Device Name: D-Laser Blue, D-Laser 16
• Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.
• Date Cleared: 2022-03-10 ( 395 days)
• Product Code: NVK , GEX , ILY
• Regulation Number: 878.4810
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K103753 , K163128 , K071687 , K930210 , K180044 , K170500
• Predicate For: K230047 , K232885 , K243764

Intended Use

D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining: incisions and draining of abscesses: tissue retraction for impressions: papillectory; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

Device Description

The dental diode laser systems, D-Laser Blue and D-Laser 16, realize oral soft tissue surgery, periodontal disease, endodontic disease, pain treatment, soft laser therapy and other oral diseases by vaporizing, carbonizing and solidifying the tissue by laser. The device features include: Using a capacitive touch screen which has the clear display and is easy to operate; Builtin large-capacity rechargeable lithium battery with longer time of endurance; The handpiece sleeve and the fiber tip can be autoclaved to prevent from cross infection; Preset more than 20 treatment procedures to reduce the difficulty of use; A secure protection mechanism that automatically shuts down the device after 5 minutes of inactivity.

The D-Laser Blue and the D-Laser 16 respectively consist of a main unit, a laser transmission system and a power adapter. The main unit includes a semiconductor laser, a power supply system and a control device, a safety protection device and a display device.

The D-Laser Blue employs the diodes with wavelengths of 976nm, 650nm and 450nm, and the device emits laser output energy in the infrared, red and blue spectra respectively. The D-Laser 16 employs the diodes with wavelengths of 976nm and 650nm, and the device emits laser output energy in the infrared, red spectra respectively.

AI/ML Overview

The provided text does not contain typical acceptance criteria and a study design for evaluating a medical device's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity). Instead, this document is a 510(k) summary for laser surgical instruments (D-Laser Blue and D-Laser 16), primarily focusing on demonstrating substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" presented are primarily comparisons of technological characteristics, indications for use, and a list of non-clinical tests confirming compliance with various electrical, safety, and biocompatibility standards. The study mentioned is a non-clinical comparison of cutting efficiency.

Therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and training set ground truth establishment) are not applicable to the type of information presented in this 510(k) summary.

Here's an attempt to extract and format the available information according to your request, with "N/A" for criteria not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the D-Laser Blue and D-Laser 16, substantial equivalence is often demonstrated by showing that the proposed device has the same intended use and similar technological characteristics to a predicate device, or that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" here are largely met by demonstrating these similarities and confirming compliance with relevant standards and functional tests.

Acceptance Criterion (Implicit/Explicit)	Reported Device Performance/Comparison (D-Laser Blue and D-Laser 16)
Indications for Use (IFU)	The indications for use of D-Laser Blue and D-Laser 16 are totally same as those of their respective predicate devices (SIROLaser Blue and SIROLaser Advance+).
Technological Characteristics	The document presents detailed comparisons of various technological characteristics, highlighting similarities and discussing how differences do not affect substantial equivalence or raise new risks. Examples of comparisons and reported findings: - Product Code: Matches GEX, ILY. - Regulation Number & Classification: Matches 21 CFR 878.4810, Class II. - Surgical IFU: Matches predicate devices. - Laser Periodontic IFU: Matches predicate devices. - Tooth Whitening IFU: Matches predicate devices. - Low Level Laser Therapy IFU: Matches predicate devices. - Application: Dental Laser (Matches). - Laser Classification: - D-Laser Blue: 976 nm (Class IV), 650 nm (Class II), 450 nm (Class IV). Predicate: 970 nm (Class IV), 660 nm (Class II), 445 nm (Class IV). Accepted based on reference devices. - D-Laser 16: 976 nm (Class IV), 650 nm (Class II). Predicate: 970 nm (Class IV), 660 nm (Class II). Accepted based on reference devices. - Laser Type: Solid state diode (Matches). - Laser Wavelength: - D-Laser Blue: 976 nm (+/-20 nm), 650 nm (+/-20 nm), 450 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687, K930210). - D-Laser 16: 976 nm (+/-20 nm), 650 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687). - Optical Power: - D-Laser Blue: 976 nm (0.2-4W CW, 7W peak), 650 nm (25-200 mW CW), 450 nm (0.2-3W CW, 4W peak). Accepted based on predicate/reference devices (e.g., K163128, K071687, K180044). - D-Laser 16: 976 nm (0.3-7W CW, 16W peak), 650 nm (25-200 mW CW). Accepted based on predicate/reference devices (e.g., K163128, K071687, K170500). - Emission Modalities: Continuous Wave, Chopped (1 Hz - 20 kHz). Accepted based on reference device K163128. - Pulse Duration: Chopped Mode (5 µsec - 0.9 sec). Accepted based on reference device K163128. - Aiming Beam: 650±20 nm, Pmax < 5 mW. Accepted based on reference device K071687 and performance test report. - Optical Fiber Surgical Tips (Fiber Diameter): 200 µm, 300 µm, 400 µm. Accepted based on K180044 and K163128. - Optical Fiber Surgical Tips (Material/Sterility): Single-use, integral fiber, plastic proximal connection, bendable stainless steel cannula, non-sterile. (Compared to sterile predicate in some aspects, but considered acceptable). - Laser Handpiece: Connected by flexible optical fiber, finger switch activation, removable/sterilizable outer sleeve. (Matches predicate). - Laser Therapy Light Guides: N/A (Predicate had curved light guides). - Activation Method: Handpiece finger switch, Wireless foot switch. (Matches predicate). - Laser Control Unit Dimensions: Different sizes, but stated "doesn't affect the substantial equivalence". - Laser Control Unit User Interface: Color touch screen graphical user interface. (Matches predicate).
Compliance with Standards	Demonstrated conformity with: - IEC 60601-1 (Basic safety and essential performance) - IEC 60601-1-2 (EMC) - IEC 60825-1 (Laser product safety) - IEC 60601-2-22 (Surgical laser equipment specific requirements) - IEC 62366 (Usability) - IEC 62304 (Software lifecycle processes) - ISO 10993-5 (Biocompatibility - cytotoxicity)
Clinical Performance (if applicable)	The document mentions summarizing studies comparing cutting efficiency of the proposed devices to the predicate devices. This indicates that functional performance testing was done. (Details on exact metrics and results are not tabulated in this summary beyond "testing results do support substantial equivalence").

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for the "cutting efficiency" comparison. This type of test typically involves laboratory measurements on tissue simulants or ex vivo tissue, not human patient data.
• Data Provenance: The document explicitly states "No human clinical data is needed for D-Laser Blue and D-Laser 16." The non-clinical tests (e.g., cutting efficiency, safety standards) would be laboratory-based, likely conducted by the manufacturer in China or by a certified testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This document describes non-clinical testing and substantial equivalence, not a diagnostic accuracy study requiring expert adjudication for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No ground truth establishment or adjudication process is described as it's not a diagnostic study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a laser surgical instrument, not an algorithm. Performance evaluation is for the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. For the non-clinical tests (like cutting efficiency), the "ground truth" would be established by objective physical measurements and engineering specifications, often against a benchmark from the predicate device.

8. The sample size for the training set

• Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• Not Applicable. No training set for machine learning is involved.

Summary

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March 10, 2022

Guilin Woodpecker Medical Instrument Co., Ltd. % Fu Ailing Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518055 China

Re: K210367

Trade/Device Name: D-Laser Blue, D-Laser 16 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: NVK, ILY, GEX Dated: January 11, 2022 Received: January 11, 2022

Dear Fu Ailing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210367

Device Name

D-Laser Blue, D-Laser 16

Indications for Use (Describe)

D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining: incisions and draining of abscesses: tissue retraction for impressions: papillectory; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K210367

This summary of 510(K) safety and effectiveness is submitted according to requirements of SMDA and 21 CFR §807.92.

5.1 Administrative Information

Date of Summary prepared	November 10, 2020
Manufacturer information	Submitter's Name: Guilin Woodpecker Medical InstrumentCo., Ltd.Address: Information Industrial Park, Guilin National High-Tech Zone, Guilin, Guangxi, 541004, ChinaContact person: Yang YunfengTEL: [phone]FAX: [phone]Mail: [e-mail]
Submission Correspondent	Company Name: Shenzhen Joyantech Consulting Co., Ltd.Address: Room 1713A, 17 Floor, Block A, Zhongguan TimesSquare, Liuxian Avenue, Xili Town, NanshanDistrict, Shenzhen, Guangdong, 518055, ChinaContact person: Ms. Fu AilingE-Mail: [e-mail]: [Logo]
Establishment registrationnumber	3005581016

5.2 Device Information

Type of 510(k) submission:	Traditional
Common Name:	Dental Diode Lasers
Trade Name:	D-Laser Blue, D-Laser 16
Model:	D-Laser Blue, D-Laser 16
Classification name:	Laser Surgical Instrument For Use In General And PlasticSurgery And In Dermatology
Review Panel:	General & Plastic Surgery
Primary Product Code:	NVK

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Version:A/0

Product: D-Laser Blue, D-Laser 16

Secondary Product Codes	GEX, ILY
Device Class:	II
Regulation Number:	21 CFR 878.4810

5.3 Predicate Devices and Reference Devices

Predicate Devices
Sponsor:	Dentsply Sirona	Dentsply Sirona
Device:	SIROLaser Blue	SIROLaser Advance+
510(K) Number:	K180044	K170500

Reference Devices

	Sirona DentalSystems GmbH	Biolase, Inc	IridexCorporation	ILT Systems,Inc.
Sponsor:
Device:	SIROLaserAdvance	Epic Pro	IQ 630-670	ACL-5500
510(K) Number:	K103753	K163128	K071687	K930210

5.4 Device Description

The dental diode laser systems, D-Laser Blue and D-Laser 16, realize oral soft tissue surgery, periodontal disease, endodontic disease, pain treatment, soft laser therapy and other oral diseases by vaporizing, carbonizing and solidifying the tissue by laser. The device features include: Using a capacitive touch screen which has the clear display and is easy to operate; Builtin large-capacity rechargeable lithium battery with longer time of endurance; The handpiece sleeve and the fiber tip can be autoclaved to prevent from cross infection; Preset more than 20 treatment procedures to reduce the difficulty of use; A secure protection mechanism that automatically shuts down the device after 5 minutes of inactivity.

The D-Laser Blue and the D-Laser 16 respectively consist of a main unit, a laser transmission system and a power adapter. The main unit includes a semiconductor laser, a power supply system and a control device, a safety protection device and a display device.

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Version:A/0

Product: D-Laser Blue, D-Laser 16

The D-Laser Blue employs the diodes with wavelengths of 976nm, 650nm and 450nm, and the device emits laser output energy in the infrared, red and blue spectra respectively. The D-Laser 16 employs the diodes with wavelengths of 976nm and 650nm, and the device emits laser output energy in the infrared, red spectra respectively.

5.5 Indications for Use

D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coaqulation and vaporization of soft tissue including marginal and interdental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

5.6 Indications for Use and Technological Characteristics of the Subject Devices Compared to the Predicate Devices

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Guilin Woodpecker	004_510(k) Summary
Product: D-Laser Blue, D-Laser 16	Version:A/0

Table 1 Comparison Between the Indications for Use and Technological Characteristics of D-Laser Blue and those of the Predicate and Reference Devices

ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
Product Code
NVK, GEX, ILY	GEX, ILY	GEX	GEX	GEX	GEX	/
Regulation Number
21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	/
Classification
Class II	Class II	Class II	Class II	Class II	Class II	/
Surgical Indication for Use
Intended for intra-	Intended for intra-	Intended for intra-	Intended for incision,	Indicated for use in	Intended for use in
and extra-oral	and extra-oral	and extra-oral	excision,	photocoagulation of	dental intraoral soft
surgery including	surgery including	surgery including	vaporization,	both anterior and	tissue, general, oral
incision, excision,	incision, excision,	incision, excision,	ablation, hemostasis,	posterior segments	maxilla-facial and	/
hemostasis,	hemostasis,	hemostasis,	or coagulation of	including:	cosmetic surgery. It is
coagulation and	coagulation and	coagulation and	intraoral and extra-	* Retinal	intended for ablating,
vaporization of soft	vaporization of soft	vaporization of soft	oral soft tissue	photocoagulation,	incising, excising,
ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
tissue including	tissue including	tissue including	(including marginal	panretinal	aporizing and	/
marginal and inter-	marginal and inter-	marginal and inter-	and interdental	photocoagulation	coagulation of soft	/
dental and epithelial	dental and epithelial	dental and epithelial	gingiva and epithelial	and intravitreal	/tissues using a fiber	/
lining of free gingiva	lining of free gingiva	lining of free gingiva	lining of free	endophotocoagulati	optic delivery system.	/
and is indicated for:	and is indicated for:	and is indicated for:	gingiva); examples	on of vascular and	The following are the	/
			include:	structural	indications for which	/
				abnormalities of the	the device will be	/
				retina and choroid	marketed:	/
				including:
frenectomy;	frenectomy;	frenectomy;	frenectomy;	> proliferative and	frenectomy;	/
frenotomy;	frenotomy;	frenotomy;	frenotomy;	nonproliferative	frenotomy;	/
biopsy;	biopsy;	biopsy;	biopsy;	diabetic	Excision and incision	/
operculectomy;	operculectomy;	operculectomy;	operculectomy;	retinopathy;	biopsies;	/
				> choroidal	operculectomy	/
implant recovery;	implant recovery;	implant recovery;	implant recovery;	neovascularization;	N/A	/
gingivectomy;	gingivectomy;	gingivectomy;	gingivectomy;	> branch retinal vein	gingivectomy;	/
gingivoplasty;	gingivoplasty;	gingivoplasty;	gingivoplasty;	occlusion;	gingivoplasty;	/
ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
gingival troughing;	gingival troughing;	gingival troughing;	gingival troughing;	> age-related	N/A	/
crown lengthening;	crown lengthening;	crown lengthening;	crown lengthening;	maculardegeneration	Soft tissue crownlengthening	/
hemostasis of donorsite;	hemostasis of donorsite;	hemostasis of donorsite;	hemostasis of donorsite;	> retinal tears anddetachments	Hemostaticassistance	/
removal ofgranulation tissue;	removal ofgranulation tissue;	removal ofgranulation tissue;	removal ofgranulation tissue;	> retinopathy ofprematurity	N/A	/
laser assisted flapsurgery;	laser assisted flapsurgery;	laser assisted flapsurgery;	laser assisted flapsurgery;	* Iridotomy,iridectomy and	N/A	/
debridement ofdiseased epitheliallining;	debridement ofdiseased epitheliallining;	debridement ofdiseased epitheliallining;	debridement ofdiseased epitheliallining;	trabeculoplasty inangle closureglaucoma and open	N/A	/
incisions and drainingof abscesses;	incisions and drainingof abscesses;	incisions and drainingof abscesses;	incisions and drainingof abscesses;	angle glaucoma	incisions and drainingof abscesses;	/
tissue retraction forimpressions;	tissue retraction forimpressions;	tissue retraction forimpressions;	tissue retraction forimpressions;	/	tissue retraction forimpressions;	/
papillectomy;	papillectomy;	papillectomy;	papillectomy;	/	Oral papillectomy	/
ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
vestibuloplasty;	vestibuloplasty;	vestibuloplasty;	vestibuloplasty;		N/A	/
excision of lesions;	excision of lesions;	excision of lesions;	excision of lesions;		N/A	/
exposure of	exposure of	exposure of	exposure of		N/A	/
unerupted/partiallyerupted teeth;	unerupted/partiallyerupted teeth;	unerupted/partiallyerupted teeth;	unerupted/partiallyerupted teeth;		N/A	/
removal ofhyperplastic tissues;	removal ofhyperplastic tissues;	removal ofhyperplastic tissues;	removal ofhyperplastic tissues;		N/A	/
treatment ofaphthous ulcers;	treatment ofaphthous ulcers;	treatment ofaphthous ulcers;	treatment ofaphthous ulcers;		treatment ofaphthous ulcers;	/
leukoplakia;	leukoplakia;	leukoplakia;	leukoplakia;		N/A	/
pulpotomy;	pulpotomy;	pulpotomy;	pulpotomy;		N/A	/
pulpotomy as adjunctto root canal therapy;	pulpotomy as adjunctto root canal therapy;	pulpotomy as adjunctto root canal therapy;	pulpotomy as adjunctto root canal therapy;		N/A	/
fibroma removal;	fibroma removal;	fibroma removal;	N/A		Removal of fibromas;	/
gingival incision andexcision;	gingival incision andexcision;	gingival incision andexcision;	N/A		gingival incision andexcision;	/

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Reference Devices

IRIDEX

Corporation

Iridex IQ Laser

System IQ 630-

670 (K071687)

Biolase, Inc

Epic Pro

(K163128)

N/A

N/A

N/A

reduction of gingivalhypertrophy.	reduction of gingivalhypertrophy.
Indications for Use

Predicate

Device

Dentsply Sirona

SIROLaser Blue

(K180044)

treatment of canker

sores; herpetic ulcers

of the oral mucosa;

laser soft tissue

curettage;

Dentsply Sirona

SIROLaser

Advance

(K103753)

treatment of canker

of the oral mucosa; laser soft tissue

curettage;

sores; herpetic ulcers

Laser Periodontic Indications for Use
laser removal ofdiseased, infected,inflamed andnecrosed soft tissue;within the periodontalpocket;	laser removal ofdiseased, infected,inflamed andnecrosed soft tissue;within the periodontalpocket;	laser removal ofdiseased, infected,inflamed andnecrosed soft tissue;within the periodontalpocket;	N/A	N/A	N/A	/
sulcular debridement(removal of diseased,infected, inflamed	sulcular debridement(removal of diseased,infected, inflamed	sulcular debridement(removal of diseased,infected, inflamed	sulcular debridement(removal of diseasedor inflamed soft tissu	N/A	Sulcular debridement(removal of diseasedor inflamed soft	/

Product: D-Laser Blue, D-Laser 16

Guilin Woodpecker

Proposed

Device

Guilin

Woodpecker

D-Laser Blue

(To be decided)

treatment of canker

sores; herpetic ulcers

of the oral mucosa;

reduction of gingival

laser soft tissue

curettage;

hypertrophy.

Version:A/0

Discussion of the

differences between

proposed device and predicate device

004_510(k) Summary

/

/

ILT Systems,

Inc.

ACL-5500

(K930210)

N/A

N/A

N/A

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004_510(k) Summary

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ProposedDevice	PredicateDevice	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
and necrosed softtissue in theperiodontal pocket toimprove clinicalindices includinggingival index,gingival bleedingindex, probe depth,attachment loss andtooth inability);	and necrosed softtissue in theperiodontal pocket toimprove clinicalindices includinggingival index,gingival bleedingindex, probe depth,attachment loss andtooth inability);	and necrosed softtissue in theperiodontal pocket toimprove clinicalindices includinggingival index,gingival bleedingindex, probe depth,attachment loss andtooth inability);	e in the periodontal pocket)	N/A	tissue in theperiodontal pocket);Photo initiation ofgingival barriers anddams
Tooth Whitening Indications for Use
Light activation forbleaching materialsfor teeth whitening.laser-assistedwhitening/bleachingof teeth.	Light activation forbleaching materialsfor teeth whitening.laser-assistedwhitening/bleachingof teeth.	N/A	Light activation forbleaching materialsfor teeth whitening.	N/A	Laser-assistedbleaching/whiteningof teeth	/
ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
Low Level Laser Therapy Indications for Use
Intended to emitenergy in the red andinfrared spectrum toprovide topicalheating for thepurpose of elevatingtissue temperaturefor the temporaryrelief of minor muscleand joint pain andstiffness, minorarthritis pain, ormuscle spasm, andfor the temporaryincrease in localblood circulation	Intended to emitenergy in the red andinfrared spectrum toprovide topicalheating for thepurpose of elevatingtissue temperaturefor the temporaryrelief of minor muscleand joint pain andstiffness, minorarthritis pain, ormuscle spasm, andfor the temporaryincrease in localblood circulation	N/A	N/A	N/A	N/A	/

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Product: D-Laser Blue, D-Laser 16

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Product: D-Laser Blue. D-Laser 16

Guilin Woodpecker

004_510(k) Summary

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ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
and/or temporary	and/or temporary
relaxation of muscles.	relaxation of muscles.
Application
Dental Laser	Dental Laser	Dental Laser	Dental Laser	IQ Laser	Curing Laser	/
Laser Classification
976 nm and 450nmLaser: Class IV650 nm Laser: ClassII	970 nm and 445 nmLaser: Class IV660 nm Laser: ClassII	970 nm: Class IV	980 nm: Class IV	630-670 nm	450 nm	According to K180044,K103753 and K163128, theupper limit is 980 nm, the lowlimit is 970 nm, so 976 nm canbe accepted. According toK930210, 450 nm can beaccepted.According to K071687, 650 nmcan be accepted.
Laser Type
Solid state diode	Solid state diode	Solid state diode	Solid state diode	Diode, Diode-	Argon Ion	/
ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
				pumped,
				frequency doubled,
				solid state
Laser Wavelength
976 nm (+/-20 nm)	970 nm (-10/+15 nm)	970 nm (+/-15 nm)	980 nm (+/-20 nm)	630-670 nm	450 nm (+/-20 nm)	According to K103753, the
(956-996)	(960-985)	(955-985)	(960-1000)		(430-470)	lowest value 955 nm can be
						accepted. According to
						K163128, the highest value
						1000 can be accepted. As a
						result, 956-996 nm can be
						accepted.
650 nm (+/-20 nm)	660 nm (+/-5 nm)					According to K071687, 630-
(630-670)	(655-665)					670 nm can be accepted.
450 nm (+/-20 nm)	445 nm (+/-5 nm)					According to K930210, 430-
(430-470)	(440-450)					470 nm can be accepted.
Optical Power
976 nm:	970 nm:	970 nm:	980 nm:	630-670 nm:	450 nm:	According to K163128, the
ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
0.2 W - 4 W(Continuous Wave)7 W (peak power)	0.2 W - 2.0 W(Continuous Wave)	7.0 W max.(Continuous Wave)14 W (peak opticalpower)	0.2 W - 25 W	≤ 5W	500 mW	highest value 25W can beaccepted, so 0.2 W - 4 W canbe accepted.
650 nm:25 mW-200 mW(Continuous Wave)	660 nm:25 mW, 50 mW, 100mW (ContinuousWave)					According to K071687, thehighest value 5 W can beaccepted. According toK180044 and K071687, 25mW-200 mW can be accepted.
450 nm:0.2 W - 3.0 W(Continuous Wave)4 W (peak power)	445 nm:0.2 W - 3.0 W(Continuous Wave)					/
Emission Modalities
• Continuous Wave• Chopped (1 Hz -20 kHz)	• Continuous Wave• Chopped (1 Hz -10 kHz)	• Continuous Wave• Chopped (1 Hz -10 kHz)• Peak Pulse (up to	• Pulsed orcontinuous (up to20 kHz)	• CW (CW-Pulse,MicroPulse, LongPulse)• Repetition rate≤	N/A	According to K163128,chopped value can be up to 20kHz, so the emission modalitiesof the proposed device can be
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)	predicate device
		20 kHz)		1kHz		accepted.
Pulse Duration
Chopped Mode:5 µsec. To 0.9 sec.	Chopped Mode:10 µsec. To 0.99 sec.	Chopped Mode:10 µsec. To 0.99 sec.Peak Pulse: 23 µsec.	50 ms to 99.9 s	10 µsec - 60 min	N/A	According to K163128, thelowest value of the pulseduration can be 50 ms and thehighest value 99.9 s, so therange of pulse duration of theproposed device can beaccepted.
Aiming Beam
650±20 nmPmax < 5 mW	660±5 nm1 mW (max.)	635 nm- 650 nm1 mW (max.)	650nm5mW (max.)	630nm-650nm	N/A	According to K071687, thelowest value 630 can beaccepted. According to the
						performance test report, thehighest value 670 nm can beaccepted.
Optical Fiber Surgical Tips

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Product: D-Laser Blue, D-Laser 16

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Guilin Woodpecker

004_510(k) Summary

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Reference Devices

Product: D-Laser Blue, D-Laser 16

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004_510(k) Summary

Discussion of the

differences between

proposed device and predicate device

Guilin Woodpecker

Proposed

Device

Predicate

Device

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	004_510(k) Summary
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ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
Fiber Diameter:200 μm, 300 μm, 400 μm,	Fiber Diameter:200 μm, 320 μm	Fiber Diameter:200 μm, 320 μm	• Fiber Diameter:• 300 μm, 400 μm	N/A	Fiber Diameter:400 μm	According to K180044 andK163128, all fiber diameters ofthe proposed device can beaccepted.
• Single-use tips.• Integral laser fiber.• Plastic proximalconnection hub.• Bendable stainlesssteel cannula.• Provided non-sterile	• Single-use tips.• Integral laser fiber.• Plastic proximalconnection hub.• Bendable stainlesssteel cannula.• Provided sterile(sterilized byethylene oxide).	• Single-use tips.• Laser fiberassembled with tipby user.• Plastic proximalconnection hub.• Bendable stainlesssteel cannula.• Provided non-sterile	• Quartz single-usetips varying inlength and corediameter• Medical gradeplastics, steel,stainless steel,aluminum, brass,and electronicparts andcomponents• Disposable	• Delivery Devicesprovided sterilepackaged & non-sterile	N/A	/
Laser Handpiece
ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
• Handpiece	• Handpiece	• Handpiece	• Handpiece		• Disposable, Barriersleeve
connected by	connected by	connected by	connected by fiberoptic cable,
flexible optical fiber	flexible optical fiber	flexible optical fiber
to control unit.	to control unit.	to control unit.
• Finger switch laseractivation.	• Finger switch laseractivation.	• Finger switch laseractivation.				/
• Removable,sterilizablestainless steelouter sleeve.	• Removable,sterilizablestainless steelouter sleeve.	• Removable,sterilizable outersleeve.
Laser Therapy Light Guides
N/A	• Curved lightguides;• 4 mm, 8mmdiameter.	N/A	N/A	N/A	N/A	/
Activation Method
• Handpiece finger	• Handpiece finger	• Handpiece finger	• Wireless	• Footswitch	• FAN forced air	/
ProposedDevice	PredicateDevice	Reference Devices				Discussion of thedifferences betweenproposed device andpredicate device
GuilinWoodpeckerD-Laser Blue(To be decided)	Dentsply SironaSIROLaser Blue(K180044)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEXCorporationIridex IQ LaserSystem IQ 630-670(K071687)	ILT Systems,Inc.ACL-5500(K930210)
switch.	switch.	switch.	footswitch.
• Wireless footswitch.	• Optional wirelessfoot switch.	• Optional wirelessfoot switch.
Laser Control Unit Dimensions
190 mm x 180 mm x200 mm	182 mm x 197 mm x189 mm	182 mm x 197 mm x189 mm	184 mm x 114 mm x165 mm	Unknown	Unknown	Different size doesn't affect thesubstantial equivalence with thepredicate.
Laser Control Unit User Interface
Color touch screengraphical userinterface	Color touch screengraphical userinterface	Color touch screengraphical userinterface	Color touch screengraphical userinterface	Manual & RemoteControls	Discreet switches	/

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Guilin Woodpecker

Product: D-Laser Blue, D-Laser 16

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Guilin Woodpecker	004_510(k) Summary
Product: D-Laser Blue, D-Laser 16	Version:A/0

Table 2 Comparison Between the Indications for Use and technological characteristics of D-Laser 16 and those of the Predicate and Reference Devices

Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
Product Code
NVK, GEX, ILY	GEX, ILY	GEX	GEX	GEX	/
Regulation Number
21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	/
Classification
Class II	Class II	Class II	Class II	Class II	/
Surgical Indication for Use
Intended for intra- and	Intended for intra- and	Intended for intra- and	Intended for incision,	Indicated for use in	/
extra-oral surgery	extra-oral surgery	extra-oral surgery	excision, vaporization,	photocoagulation of both
including incision,	including incision,	including incision,	ablation, hemostasis, or	anterior and posterior
excision, hemostasis,	excision, hemostasis,	excision, hemostasis,	coagulation of intraoral	segments including:
coagulation and	coagulation and	coagulation and	and extra-oral soft tissue	* Retinal
vaporization of soft tissue	vaporization of soft tissue	vaporization of soft tissue	(including marginal and	photocoagulation,
including marginal and	including marginal and	including marginal and	interdental gingiva and	panretinal
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
inter-dental and epithelial	inter-dental and epithelial	inter-dental and epithelial	epithelial lining of free	photocoagulation and
lining of free gingiva and is	lining of free gingiva and is	lining of free gingiva and is	gingiva); examples	intravitreal
indicated for:	indicated for:	indicated for:	include:	endophotocoagulation of
				vascular and structural
				abnormalities of the
				retina and choroid
				including:
frenectomy; frenotomy;	frenectomy; frenotomy;	frenectomy; frenotomy;	frenectomy; frenotomy;	> proliferative and	/
biopsy; operculectomy;	biopsy; operculectomy;	biopsy; operculectomy;	biopsy; operculectomy;	nonproliferative diabetic	/
implant recovery;	implant recovery;	implant recovery;	implant recovery;	retinopathy;	/
gingivectomy;	gingivectomy;	gingivectomy;	gingivectomy;	> choroidal	/
gingivoplasty;	gingivoplasty;	gingivoplasty;	gingivoplasty;	neovascularization;	/
gingival troughing;	gingival troughing;	gingival troughing;	gingival troughing;	> branch retinal vein	/
crown lengthening;	crown lengthening;	crown lengthening;	crown lengthening;	occlusion;	/
hemostasis of donor site;	hemostasis of donor site;	hemostasis of donor site;	hemostasis of donor site;	> age-related maculardegeneration	/
removal of granulation	removal of granulation	removal of granulation	removal of granulation	> retinal tears and	/
tissue:	tissue:	tissue:	tissue:		/
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
laser assisted flapsurgery;	laser assisted flapsurgery;	laser assisted flapsurgery;	laser assisted flapsurgery;	detachments	/
debridement of diseasedepithelial lining;	debridement of diseasedepithelial lining;	debridement of diseasedepithelial lining;	debridement of diseasedepithelial lining;	> retinopathy ofprematurity	/
incisions and draining ofabscesses;	incisions and draining ofabscesses;	incisions and draining ofabscesses;	incisions and draining ofabscesses;	* Iridotomy, iridectomy andtrabeculoplasty in angleclosure glaucoma andopen angle glaucoma	/
tissue retraction forimpressions;	tissue retraction forimpressions;	tissue retraction forimpressions;	tissue retraction forimpressions;		/
papillectomy;	papillectomy;	papillectomy;	papillectomy;		/
vestibuloplasty;	vestibuloplasty;	vestibuloplasty;	vestibuloplasty;		/
excision of lesions;	excision of lesions;	excision of lesions;	excision of lesions;		/
exposure ofunerupted/partiallyerupted teeth;	exposure ofunerupted/partiallyerupted teeth;	exposure ofunerupted/partiallyerupted teeth;	exposure ofunerupted/partiallyerupted teeth;		/
removal of hyperplastictissues;	removal of hyperplastictissues;	removal of hyperplastictissues;	removal of hyperplastictissues;		/
treatment of aphthousulcers;	treatment of aphthousulcers;	treatment of aphthousulcers;	treatment of aphthousulcers;		/
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
leukoplakia;	leukoplakia;	leukoplakia;	leukoplakia;		/
pulpotomy; pulpotomy asadjunct to root canaltherapy;	pulpotomy; pulpotomy asadjunct to root canaltherapy;	pulpotomy; pulpotomy asadjunct to root canaltherapy;	pulpotomy; pulpotomy asadjunct to root canaltherapy;		/
fibroma removal; gingivalincision and excision;	fibroma removal; gingivalincision and excision;	fibroma removal; gingivalincision and excision;	N/A		/
treatment of canker sores;herpetic ulcers of the oralmucosa;	treatment of canker sores;herpetic ulcers of the oralmucosa;	treatment of canker sores;herpetic ulcers of the oralmucosa;	N/A		/
laser soft tissue curettage;	laser soft tissue curettage;	laser soft tissue curettage;	N/A		/
reduction of gingivalhypertrophy.	reduction of gingivalhypertrophy.	reduction of gingivalhypertrophy.	N/A		/
Laser Periodontic Indications for Use
laser removal of diseased,infected, inflamed andnecrosed soft tissue;within the periodontal	laser removal of diseased,infected, inflamed andnecrosed soft tissue;within the periodontal	laser removal of diseased,infected, inflamed andnecrosed soft tissue;within the periodontal	N/A	N/A	/
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
pocket;	pocket;	pocket;
sulcular debridement(removal of diseased,infected, inflamed andnecrosed soft tissue in theperiodontal pocket toimprove clinical indicesincluding gingival index,gingival bleeding index,probe depth, attachmentloss and tooth inability);	sulcular debridement(removal of diseased,infected, inflamed andnecrosed soft tissue in theperiodontal pocket toimprove clinical indicesincluding gingival index,gingival bleeding index,probe depth, attachmentloss and tooth inability);	sulcular debridement(removal of diseased,infected, inflamed andnecrosed soft tissue in theperiodontal pocket toimprove clinical indicesincluding gingival index,gingival bleeding index,probe depth, attachmentloss and tooth inability);	sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)	N/A	/
Tooth Whitening Indications for Use
Light activation forbleaching materials forteeth whitening.	Light activation forbleaching materials forteeth whitening.	N/A	Light activation forbleaching materials forteeth whitening.	N/A	/
Laser-assistedwhitening/bleaching ofteeth.	laser-assistedwhitening/bleaching ofteeth.	N/A	N/A	N/A	/
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
Low Level Laser Therapy Indications for Use
Intended to emit energy inthe red and infraredspectrum to providetopical heating for thepurpose of elevatingtissue temperature for thetemporary relief of minormuscle and joint pain andstiffness, minor arthritispain, or muscle spasm,and for the temporaryincrease in local bloodcirculation and/ortemporary relaxation ofmuscles.	Intended to emit energy inthe red and infraredspectrum to providetopical heating for thepurpose of elevatingtissue temperature for thetemporary relief of minormuscle and joint pain andstiffness, minor arthritispain, or muscle spasm,and for the temporaryincrease in local bloodcirculation and/ortemporary relaxation ofmuscles.	N/A	N/A	N/A	/
Application
Dental Laser	Dental Laser	Dental Laser	Dental Laser	IQ Laser	/
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
Laser Classification
976 nm Laser: Class IV	970 nm Laser: Class IV	970 nm: Class IV	980 nm: Class IV	630-670 nm	According to K170500 andK163128, 976 nm can beaccepted.
650 nm Laser: Class II	660 nm Laser: Class II				According to K071687, 650 nmcan be accepted.
Laser Type
Solid state diode	Solid state diode	Solid state diode	Solid state diode	Diode, Diode-pumped,frequency doubled, solidstate	/
Laser Wavelength
976 nm (+/-20 nm)(956-996)	970 nm (-10/+15 nm)(960-985)	970 nm (+/-15 nm)(955-985)	980 nm (+/-20 nm)(960-1000)	630-670 nm	According to K103753, thelowest value 955 nm can beaccepted. According toK163128, the highest value1000 can be accepted. As aresult, 956-996 nm can be
(Continuous Wave)16 W (peak power)	14 W (peak optical power)	(Continuous Wave)14 W (peak optical power)			accepted, so 0.2 W - 4 W canbe accepted.
650 nm:25 mW-200 mW(Continuous Wave)	660 nm:25 mW, 50 mW, 100 mW				According to K071687, thehighest value 5 W can beaccepted. According toK170500 and K071687, 25mW-200 mW can be accepted
Emission Modalities
• Continuous Wave• Chopped (1 Hz - 20 kHz)	• Continuous Wave• Chopped (1 Hz - 10 kHz)	• Continuous Wave• Chopped (1 Hz - 10 kHz)	• Pulsed or continuous(up to 20 kHz)	• CW (CW-Pulse,MicroPulse, Long Pulse)• Repetition rate≤ 1kHz	According to K163128,chopped value can be up to 20kHz, so the emission modalities
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
	• Peak Pulse (1.5 kHz -	• Peak Pulse (up to 20			of the proposed device can be
	20 kHz)	kHz)			accepted.
Pulse Duration
Chopped Mode:5 µsec. To 0.9 sec.	Chopped Mode:10 µsec. to 0.99 sec.Peak Pulse Mode: 23µsec.	Chopped Mode:10 µsec. To 0.99 sec.Peak Pulse Mode: 23µsec.	50 ms to 99.9 s	10 µsec - 60 min	According to K163128, thelowest value of the pulseduration can be 50 ms and thehighest value 99.9 s, so therange of pulse duration of theproposed device can beaccepted.
Alming Beam
650±20 nm	660±5 nm	635 nm- 650 nm	650nm		According to K071687, the
$P_{max}$ < 5 mW	1 mW (max.)	1 mW (max.)	5mW (max.)	630nm-650nm	lowest value 630 can be
					accepted. According to the
					performance test report, the
					highest value 670 nm can be
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
					accepted.
Optical Fiber Surgical Tips
Fiber Diameter:200 μm, 300 μm, 400 μm,	Fiber Diameter:200 μm, 320 μm	Fiber Diameter:200 μm, 320 μm	• Fiber Diameter:• 300 μm, 400 μm	N/A	According to K180044 andK163128, all fiber diameters ofthe proposed device can beaccepted.
• Single-use tips.• Integral laser fiber.• Plastic proximalconnection hub.• Bendable stainless steelcannula.• Provided non-sterile	• Single-use tips.• Integral laser fiber.• Plastic proximalconnection hub.• Bendable stainless steelcannula.• Provided sterile(sterilized by ethyleneoxide).	• Single-use tips.• Laser fiber assembledwith tip by user.• Plastic proximalconnection hub.• Bendable stainless steelcannula.• Provided non-sterile	• Quartz single-use tipsvarying in length andcore diameter• Medical grade plastics,steel, stainless steel,aluminum, brass, andelectronic parts andcomponents• Disposable	• Delivery Devicesprovided sterilepackaged & non-sterile	/
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
• Handpiece connectedby flexible optical fiberto control unit.• Finger switch laseractivation.• Removable, sterilizablestainless steel outersleeve.	• Handpiece connectedby flexible optical fiberto control unit.• Finger switch laseractivation.• Removable, sterilizablestainless steel outersleeve.	• Handpiece connectedby flexible optical fiberto control unit.• Finger switch laseractivation.• Removable, sterilizableouter sleeve.	• Handpiece connectedby fiber optic cable,		/
Laser Therapy Light Guides
N/A	• Curved light guides;• 4 mm, 8mm diameter.	N/A	N/A	N/A	/
Activation Method
• Handpiece fingerswitch.• Wireless foot switch.	• Handpiece fingerswitch.• Optional wireless footswitch.	• Handpiece fingerswitch.• Optional wireless footswitch.	• Wireless footswitch.	• Footswitch	/
Laser Control Unit Dimensions
Proposed Device	Predicate Device	Reference Devices			Discussion of thedifferences betweenproposed device andpredicate device
Guilin WoodpeckerD-Laser 16(To be decided)	Dentsply SironaSIROLaserAdvance+(K170500)	Dentsply SironaSIROLaserAdvance(K103753)	Biolase, IncEpic Pro(K163128)	IRIDEX CorporationIridex IQ LaserSystem IQ 630-670(K071687)
190 mm x 180 mm x 200mm	182 mm x 197 mm x 189mm	182 mm x 197 mm x 189mm	184 mm x 114 mm x 165mm	Unknown	Different size doesn't affect thesubstantial equivalence with thepredicate.
Laser Control Unit User Interface					/
Color touch screen	Color touch screen	Color touch screen	Color touch screen	Manual & RemoteControls
graphical user interface	graphical user interface	graphical user interface	graphical user interface

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004_510(k) Summary

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004_510(k) Summary

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004_510(k) Summary

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004_510(k) Summary

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Product: D-Laser Blue, D-Laser 16

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004_510(k) Summary

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980 nm:

0.2 W - 25 W

Dentsply Sirona

SIROLaser

Advance

(K103753)

970 nm:

7.0 W max.

Product: D-Laser Blue, D-Laser 16

Predicate Device

Dentsply Sirona

SIROLaser

Advance+

(K170500)

660 nm (+/-5 nm)

0.2 W - 7.0 W (CW)

(655-665)

970 nm:

Reference Devices

Biolase, Inc

Epic Pro

(K163128)

IRIDEX Corporation

Iridex IQ Laser

System IQ 630-670

(K071687)

630-670 nm:

≤ 5W

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004_510(k) Summary

Discussion of the differences between

proposed device and predicate device

According to K071687, 630-

670 nm can be accepted.

According to K163128, the

highest value 25W can be

accepted.

Guilin Woodpecker

Proposed Device

Guilin Woodpecker

D-Laser 16

(To be decided)

650 nm (+/-20 nm)

Optical Power

(630-670)

976 nm:

0.3 W - 7 W

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Product: D-Laser Blue, D-Laser 16

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Product: D-Laser Blue, D-Laser 16

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Product: D-Laser Blue, D-Laser 16

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Product: D-Laser Blue, D-Laser 16

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From above two tables, the proposed device D-Laser Blue and the predicate device SIROLaser Blue, and the proposed device D-Laser 16 and the predicate device SIROLaser Advance+ have indications for use respectively. Although there are subtle technological characteristic differences between the proposed devices, it is clear that the technological characteristic differences discussed do not affect the substantial equivalence.

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5.7 Brief discussion of the non-clinical tests

To verify the performance requirements of D-Laser Blue and D-Laser16, the following tests were performed. It shows that the testing results do support substantial equivalence.

• Verify the conformity of the proposed devices with the requirements of IEC 60601-1:(Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
• Verify the conformity of the proposed devices with the requirements of IEC 60601-1-2:(Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility).
• Verify the conformity of the proposed devices to IEC 60825-1 (Safety of laser products Part 1: Equipment classification and requirements).
• Verify the performance of the proposed devices according to IEC 60601-2-22: (Medical electrical equipment Part 2: Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).
• Conduct usability study in conformity with IEC 62366 (Medical devices Application of usability engineering to medical devices).
• Validate the devices' software in conformity with IEC 62304 (Medical device software Software lifecycle processes).
• Evaluate the biocompatibility of patient contacting components of the proposed devices according to the requirements ISO 10993-5 (Biological evaluation of medical devices Part 5: Test for cytotoxicity).
• Summarize studies conducted utilizing D-Laser Blue comparing the cutting efficiency of the predicate device SIROLaser Advance+ /SIROLaser Blue. ( Note: D-Laser 16 vs SIROLaser Advance+; D-Laser Blue vs SIROLaser Blue.

5.8 Brief discussion of clinical tests

No human clinical data is needed for D-Laser Blue and D-Laser 16.

5.9 Other information (such as required by FDA guidance/Test)

N/A.

5.10 Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Guilin Woodpecker Medical Instrument Co., Ltd. concludes that:

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• . The indications for use of D-Laser Blue and D-Laser 16 are totally same as those of the predicate devices.
• The technological characteristic differences between D-Laser Blue and SIROLaser Blue, and . between D-Laser 16 and SIROLaser Advance+ do not affect the substantial equivalence, so no new risk is raised.
• Demonstrated by the safety and performance tests, the characteristics of D-Laser Blue and D-Laser 16 are respectively equivalent to those of the predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.