Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the laser technology and its physical effects on tissue, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning. The "preset more than 20 treatment procedures" suggests pre-programmed settings, not adaptive or learning capabilities.

Therapeutic

Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "Low Level Laser Therapy" to provide "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," which are therapeutic applications. Additionally, the "Device Description" mentions "pain treatment, soft laser therapy".

Diagnostic

No.

The device is intended for surgical and therapeutic procedures, such as incision, excision, hemostasis, coagulation, vaporization of soft tissue, teeth whitening, and low-level laser therapy for pain relief and increased blood circulation. It is not described as performing any diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device consists of a main unit, a laser transmission system, and a power adapter, which are hardware components. It also mentions a semiconductor laser, power supply system, control device, safety protection device, and display device. The performance studies include testing against hardware standards like IEC 60601-1 and IEC 60825-1.

IVD (In Vitro Diagnostic)

Based on the provided text, the D-Laser Blue and D-Laser 16 devices are not In Vitro Diagnostic (IVD) devices.

Here's why:

Intended Use: The intended use clearly describes surgical procedures performed directly on soft tissue (incision, excision, hemostasis, coagulation, vaporization), teeth whitening, and low-level laser therapy for pain relief and circulation. These are all procedures performed in vivo (on a living organism), not in vitro (outside the body, typically on biological samples).
Device Description: The device description details a laser system designed to interact directly with tissue through vaporization, carbonization, and solidification. This is consistent with a surgical or therapeutic device, not a device that analyzes biological samples.
Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information based on sample analysis
- Using reagents or assays

The device is a surgical and therapeutic laser system for dental applications.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

NVK, ILY, GEX

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 semiconductor laser, a power supply system and a control device, a safety protection device and a display device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intra- and extra-oral

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Key Metrics

Not Found

Predicate Device(s)

K180044, K170500

Reference Device(s)

K103753, K163128, K071687, K930210

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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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4

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 Instrument
Co., Ltd.
Address: Information Industrial Park, Guilin National High-
Tech Zone, Guilin, Guangxi, 541004, China
Contact person: Yang Yunfeng
TEL: +86-773-2350532
FAX: +86-773-5822450
Mail: ipr@glwoodpecker.com
Submission Correspondent	Company Name: Shenzhen Joyantech Consulting Co., Ltd.
Address: Room 1713A, 17 Floor, Block A, Zhongguan Times
Square, Liuxian Avenue, Xili Town, Nanshan
District, Shenzhen, Guangdong, 518055, China
Contact person: Ms. Fu Ailing
E-Mail: aileen@cefda.com
Image: [Logo]
Establishment registration
number	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 Plastic
Surgery And In Dermatology
Review Panel:	General & Plastic Surgery
Primary Product Code:	NVK

5

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 Dental
Systems GmbH | Biolase, Inc | Iridex
Corporation | ILT Systems,
Inc. |
|----------------|-------------------------------|--------------|-----------------------|----------------------|
| Sponsor: | | | | |
| Device: | SIROLaser
Advance | 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.

6

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

7

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

| Proposed
Device | Predicate
Device | Reference Devices | | | | Discussion of the
differences between
proposed device and
predicate device |
|---------------------------------------------------------|--------------------------------------------------|------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------|
| Guilin
Woodpecker
D-Laser Blue
(To be decided) | Dentsply Sirona
SIROLaser Blue
(K180044) | Dentsply Sirona
SIROLaser
Advance
(K103753) | Biolase, Inc
Epic Pro
(K163128) | IRIDEX
Corporation
Iridex IQ Laser
System 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, | |
| Proposed
Device | Predicate
Device | Reference Devices | | | | Discussion of the
differences between
proposed device and
predicate device |
| Guilin
Woodpecker
D-Laser Blue
(To be decided) | Dentsply Sirona
SIROLaser Blue
(K180044) | Dentsply Sirona
SIROLaser
Advance
(K103753) | Biolase, Inc
Epic Pro
(K163128) | IRIDEX
Corporation
Iridex IQ Laser
System 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; | / |
| Proposed
Device | Predicate
Device | Reference Devices | | | | Discussion of the
differences between
proposed device and
predicate device |
| Guilin
Woodpecker
D-Laser Blue
(To be decided) | Dentsply Sirona
SIROLaser Blue
(K180044) | Dentsply Sirona
SIROLaser
Advance
(K103753) | Biolase, Inc
Epic Pro
(K163128) | IRIDEX
Corporation
Iridex IQ Laser
System 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; | macular
degeneration | Soft tissue crown
lengthening | / |
| hemostasis of donor
site; | hemostasis of donor
site; | hemostasis of donor
site; | hemostasis of donor
site; | > retinal tears and
detachments | Hemostatic
assistance | / |
| removal of
granulation tissue; | removal of
granulation tissue; | removal of
granulation tissue; | removal of
granulation tissue; | > retinopathy of
prematurity | N/A | / |
| laser assisted flap
surgery; | laser assisted flap
surgery; | laser assisted flap
surgery; | laser assisted flap
surgery; | * Iridotomy,
iridectomy and | N/A | / |
| debridement of
diseased epithelial
lining; | debridement of
diseased epithelial
lining; | debridement of
diseased epithelial
lining; | debridement of
diseased epithelial
lining; | trabeculoplasty in
angle closure
glaucoma and open | N/A | / |
| incisions and draining
of abscesses; | incisions and draining
of abscesses; | incisions and draining
of abscesses; | incisions and draining
of abscesses; | angle glaucoma | incisions and draining
of abscesses; | / |
| tissue retraction for
impressions; | tissue retraction for
impressions; | tissue retraction for
impressions; | tissue retraction for
impressions; | / | tissue retraction for
impressions; | / |
| papillectomy; | papillectomy; | papillectomy; | papillectomy; | / | Oral papillectomy | / |
| Proposed
Device | Predicate
Device | Reference Devices | | | | Discussion of the
differences between
proposed device and
predicate device |
| Guilin
Woodpecker
D-Laser Blue
(To be decided) | Dentsply Sirona
SIROLaser Blue
(K180044) | Dentsply Sirona
SIROLaser
Advance
(K103753) | Biolase, Inc
Epic Pro
(K163128) | IRIDEX
Corporation
Iridex IQ Laser
System 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/partially
erupted teeth; | unerupted/partially
erupted teeth; | unerupted/partially
erupted teeth; | unerupted/partially
erupted teeth; | | N/A | / |
| removal of
hyperplastic tissues; | removal of
hyperplastic tissues; | removal of
hyperplastic tissues; | removal of
hyperplastic tissues; | | N/A | / |
| treatment of
aphthous ulcers; | treatment of
aphthous ulcers; | treatment of
aphthous ulcers; | treatment of
aphthous ulcers; | | treatment of
aphthous ulcers; | / |
| leukoplakia; | leukoplakia; | leukoplakia; | leukoplakia; | | N/A | / |
| pulpotomy; | pulpotomy; | pulpotomy; | pulpotomy; | | N/A | / |
| pulpotomy as adjunct
to root canal therapy; | pulpotomy as adjunct
to root canal therapy; | pulpotomy as adjunct
to root canal therapy; | pulpotomy as adjunct
to root canal therapy; | | N/A | / |
| fibroma removal; | fibroma removal; | fibroma removal; | N/A | | Removal of fibromas; | / |
| gingival incision and
excision; | gingival incision and
excision; | gingival incision and
excision; | N/A | | gingival incision and
excision; | / |

8

004_510(k) Summary

Version:A/0

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004_510(k) Summary

Version:A/0

10

004_510(k) Summary

Version:A/0

11

Reference Devices

IRIDEX

Corporation

Iridex IQ Laser

System IQ 630-

670 (K071687)

Biolase, Inc

Epic Pro

(K163128)

N/A

| reduction of gingival
hypertrophy. | reduction of gingival
hypertrophy. |
|---------------------------------------|---------------------------------------|
| 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 of
diseased, infected,
inflamed and
necrosed soft tissue;
within the periodontal
pocket;	laser removal of
diseased, infected,
inflamed and
necrosed soft tissue;
within the periodontal
pocket;	laser removal of
diseased, infected,
inflamed and
necrosed soft tissue;
within the periodontal
pocket;	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 diseased
or inflamed soft tissu	N/A	Sulcular debridement
(removal of diseased
or 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

12

004_510(k) Summary

Version:A/0

| Proposed
Device | Predicate
Device | Reference Devices | | | Discussion of the
differences between
proposed device and
predicate device | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Guilin
Woodpecker
D-Laser Blue
(To be decided) | Dentsply Sirona
SIROLaser Blue
(K180044) | Dentsply Sirona
SIROLaser
Advance
(K103753) | Biolase, Inc
Epic Pro
(K163128) | IRIDEX
Corporation
Iridex IQ Laser
System IQ 630-
670
(K071687) | ILT Systems,
Inc.
ACL-5500
(K930210) | |
| 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); | 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); | 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); | e in the periodontal p
ocket) | N/A | tissue in the
periodontal pocket);
Photo initiation of
gingival barriers and
dams | |
| Tooth Whitening Indications for Use | | | | | | |
| Light activation for
bleaching materials
for teeth whitening.
laser-assisted
whitening/bleaching
of teeth. | Light activation for
bleaching materials
for teeth whitening.
laser-assisted
whitening/bleaching
of teeth. | N/A | Light activation for
bleaching materials
for teeth whitening. | N/A | Laser-assisted
bleaching/whitening
of teeth | / |
| Proposed
Device | Predicate
Device | Reference Devices | | | | Discussion of the
differences between
proposed device and
predicate device |
| Guilin
Woodpecker
D-Laser Blue
(To be decided) | Dentsply Sirona
SIROLaser Blue
(K180044) | Dentsply Sirona
SIROLaser
Advance
(K103753) | Biolase, Inc
Epic Pro
(K163128) | IRIDEX
Corporation
Iridex IQ Laser
System IQ 630-
670
(K071687) | ILT Systems,
Inc.
ACL-5500
(K930210) | |
| Low Level Laser Therapy Indications for Use | | | | | | |
| 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 | 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 | N/A | N/A | N/A | N/A | / |

13

Product: D-Laser Blue, D-Laser 16

Version:A/0

14

Product: D-Laser Blue. D-Laser 16

Guilin Woodpecker

004_510(k) Summary

Version:A/0

| Proposed
Device | Predicate
Device | Reference Devices | | | | Discussion of the
differences between
proposed device and
predicate device |
|----------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Guilin
Woodpecker
D-Laser Blue
(To be decided) | Dentsply Sirona
SIROLaser Blue
(K180044) | Dentsply Sirona
SIROLaser
Advance
(K103753) | Biolase, Inc
Epic Pro
(K163128) | IRIDEX
Corporation
Iridex IQ Laser
System 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 450nm
Laser: Class IV

650 nm Laser: Class
II | 970 nm and 445 nm
Laser: Class IV

Peak Pulse Mode: 23
µsec. | Chopped Mode:
10 µsec. To 0.99 sec.

Peak Pulse Mode: 23
µsec. | 50 ms to 99.9 s | 10 µsec - 60 min | According to K163128, the
lowest value of the pulse
duration can be 50 ms and the
highest value 99.9 s, so the
range of pulse duration of the
proposed device can be
accepted. |
| Alming Beam | | | | | |
| 650±20 nm | 660±5 nm | 635 nm- 650 nm | 650nm | | According to K071687, the |
| $P_{max}$