(163 days)
No
The summary describes a laser system for surgical and therapeutic applications, focusing on different wavelengths and their intended uses. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The device description focuses on the hardware components and energy delivery.
Yes
The "Intended Use / Indications for Use" section explicitly lists various therapeutic applications, including surgical procedures, pain relief for minor muscle and joint issues, and treatment of various oral conditions.
No
The device description and intended use primarily describe surgical, therapeutic (pain relief, blood circulation, muscle relaxation), and aesthetic (whitening) applications; it does not mention diagnostic purposes.
No
The device description explicitly states it is a "surgical device" that utilizes a "solid state diode as laser energy source" and a "delivery system consisting of a flexible fiber connecting the laser source and the handpiece." It also mentions a "power supply system and microcomputer control system." These are all hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Dawn Diode Laser System is a surgical device designed for soft tissue procedures and light activation for bleaching materials. It directly interacts with the patient's body for treatment and cosmetic purposes.
- Intended Use: The listed intended uses are all related to surgical interventions, therapy, and teeth whitening, none of which involve the analysis of in vitro specimens.
The device's function and intended uses fall under the category of therapeutic or surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
450 nm, 635 nm and 980 nm Diode Laser: Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tıssue; 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 bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening: Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: 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.
810 nm Diode Laser in dentistry: Surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue - Gingival troughing for crown impression - Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis and coagulation - Excisional and incisional biopsies - Fibroma removal - Frenectomy and frenotomy - Oral papillectomies - Soft tissue crown lengthening - Treatment of aphthous ulcers - Treatment of herpetic lesions - Periodontology; - Laser soft tissue curettage - Laser soft tissue curettage - Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket - Cosmetic Dentistry; - Laser-assisted bleaching/whitening of the teeth - Light activation for bleaching materials for teeth whitening - Implant recovery
810 nm Diode Laser in therapy: Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
1064 nm Diode Laser in dentistry: - Excisional and incisional biopsies; - Excision and vaporization of herpes simplex I and II; - Frenectomy and frenotomy; - Gingivectomy; - Gingivoplasty; - Gingival incision and excision; - Hemostasis; - Implant recovery; - Operculectomy; - Pulpotomy and pulpotomy as an adjunct to root canal therapy; - Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy; · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility): · Treatment of aphthous ulcers and herpetic lesions
Product codes (comma separated list FDA assigned to the subject device)
NVK, ILY, GEX, EEG
Device Description
The Dawn Diode Laser System manufactured by SWOT LASERS is a surgical device at the cutting edge of technology, designed for a wide variety of soft tissue procedures. The Dawn Diode Laser System utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of footswitch. This laser instrument consists of fiber connecting diode laser system, power supply system and microcomputer control system. The Dawn Diode Laser System employs the diodes with wavelengths of 450nm, 635nm, 810nm, 980nm and 1064nm, and the device emits laser output energy in blue (450nm), red (635nm), orange (980nm) spectra respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra- and extra-oral surgery (soft tissue including marginal and inter-dental and epithelial lining of free gingiva), periodontal pocket, teeth, minor muscle and joint.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed to verify the performance requirements of Dawn Diode Laser System. The testing results are stated to support substantial equivalence. No human clinical data is needed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K071687, K163128, K111643, K202991, K222701
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2024
Shanghai Wonderful Opto-Electrics Tech Co., Ltd. % Fu Ailing Consultant Aisnwei Information Technology Co., Ltd. 5F, Block 82, Zhangkeng 2nd Community, Minzhi Street, Longhua District Shenzhen, Guangdong 518109 CHINA
Re: K232885
Trade/Device Name: Dawn Diode Laser System 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, EEG Dated: October 10, 2023 Received: October 16, 2023
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 (the 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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
510(k) Number (if known) K232885
Device Name
Dawn Diode Laser System
Indications for Use (Describe)
450 nm, 635 nm and 980 nm Diode Laser:
· Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tıssue; 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 bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening:
• Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy:
· 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.
810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology
· Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue
- · Gingival troughing for crown impression
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
- · Excisional and incisional biopsies
- · Fibroma removal
- · Frenectomy and frenotomy
- · Oral papillectomies
- · Soft tissue crown lengthening
- · Treatment of aphthous ulcers
- · Treatment of herpetic lesions
- · Periodontology;
- · Laser soft tissue curettage
- · Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
4
- · Cosmetic Dentistry;
- · Laser-assisted bleaching/whitening of the teeth
- · Light activation for bleaching materials for teeth whitening
- · Implant recovery
810 nm Diode Laser in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
1064 nm Diode Laser in dentistry:
- · Excisional and incisional biopsies;
- · Excision and vaporization of herpes simplex I and II;
- · Frenectomy and frenotomy;
- · Gingivectomy;
- · Gingivoplasty;
- · Gingival incision and excision;
- · Hemostasis;
- · Implant recovery;
- · Operculectomy;
- · Pulpotomy and pulpotomy as an adjunct to root canal therapy;
- · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
· Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility):
· Treatment of aphthous ulcers and herpetic lesions
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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5
510(k) Summary-K232885
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 | May 27, 2023 |
|---|---|
| Manufacturer information | Submitter's Name: Shanghai Wonderful Opto-Electrics Tech Co., Ltd. |
| Address: 2F, Building 11, Lane 1175, Tongpu Rd., Putuo District, Shanghai, 200333 China | |
| Contact person: Lily Zhou | |
| Mobile phone: +86-13701883482 | |
| Mail: laser@wonderful-sh.com | |
| Submission Correspondent | Company Name: Aisnwei Information Technology Co., Ltd. |
| Address: 5F, Block 82, Zhangkeng 2nd Community, Minzhi Street, Longhua District, Shenzhen, 518109 China | |
| Contact person: Ms. Fu Ailing | |
| Mobile phone: +86-13538216349 | |
| E-Mail: fuailing@aisnwei.com | |
| Establishment registration number | 3004505220 |
5.2 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Common Name: | Dawn Laser |
| Trade Name: | Dawn Diode Laser System |
| Model: | Dawn |
| Classification name: | Laser Surgical Instrument For Use In General And Plastic |
| Surgery And In Dermatology | |
| Review Panel: | General & Plastic Surgery |
| Primary Product Code: | NVK |
| Secondary Product Codes | GEX, ILY |
6
| Shanghai Wonderful | 510(k) Summary |
|---|---|
| Product: Dawn Laser | Version:A/1 |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4810 |
5.3 Predicate Devices and Reference Devices
| Predicate device | 510(k) number: K210367
Trade name: D-Laser Blue, D-Laser 16
Product code: NVK, ILY, GEX |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) number: K221712
Trade name: Fotona XPulse Laser System Family (XPulse
1064 nm, XPulse 810 nm, XPulse 980 nm
Product code: GEX |
| Reference device | 510(k) number: K071687
Trade name: Family of IRIDEX® IQ Laser System (IQ532,
IQ577, IQ 630-670, IQ810)
Product code: GEX |
| | 510(k) number: K163128
Trade name: Epic Pro
Product code: GEX |
| | 510(k) number: K111643
Trade name: Opto Mitra Yellow Laser
Product code: GEX |
| | 510(k) number: K202991
Trade name: Fotona XPulse Pro Laser Platform
Product code: GEX |
| | 510(k) number: K222701
Trade name: MANTA Laser
Product code: GEX |
5.4 Device Description
The Dawn Diode Laser System manufactured by SWOT LASERS is a surgical device at the cutting edge of technology, designed for a wide variety of soft tissue procedures. The Dawn Diode Laser System utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of footswitch.
7
Version:A/1
Product: Dawn Laser
This laser instrument consists of fiber connecting diode laser system, power supply system and microcomputer control system.
The Dawn Diode Laser System employs the diodes with wavelengths of 450nm, 635nm, 810nm, 980nm and 1064nm, and the device emits laser output energy in blue (450nm), red (635nm), orange (980nm) spectra respectively.
5.5 Intended Use/Indications for Use
450 nm, 635 nm and 980 nm Diode Laser:
-
Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; 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, infected, 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: -
Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: -
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
8
Version:A/1
and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
810 nm Diode Laser in dentistry:
- Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolarynqology, ophthalmology, and pulmonology
- Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue
- Gingival troughing for crown impression
- Gingivectomy
- · Gingivoplasty
- Gingival incision and excision
- · Hemostasis and coagulation
- Excisional and incisional biopsies
- Fibroma removal
- Frenectomy and frenotomy
- Oral papillectomies
- · Soft tissue crown lengthening
- Treatment of aphthous ulcers
- Treatment of herpetic lesions
- · Periodontology;
- Laser soft tissue curettage
- Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Cosmetic Dentistry:
- Laser-assisted bleaching/whitening of the teeth
- Light activation for bleaching materials for teeth whitening
- Implant recovery
9
810 nm Diode Laser in therapy:
-
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
1064 nm Diode Laser in dentistry: -
Excisional and incisional biopsies:
-
· Excision and vaporization of herpes simplex I and II;
-
· Frenectomy and frenotomy;
-
· Gingivectomy;
-
· Gingivoplasty;
-
· Gingival incision and excision;
-
· Hemostasis;
-
Implant recovery;
-
· Operculectomy;
-
· Pulpotomy and pulpotomy as an adjunct to root canal therapy;
-
Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
-
Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility);
-
· Treatment of aphthous ulcers and herpetic lesions
5.6 Indications for Use and Technological Characteristics of the Subject Devices Compared to the Predicate Devices
10
Product: Dawn Laser
003_510(k) Summary
Version:A/1
Table 1 Comparison Between the Indications for Use and Technological Characteristics of Dawn Diode Laser System
| Proposed Device | Predicate Device 1 | Discussion of the differences between proposed device and predicate device |
|---|---|---|
| Shanghai Wonderful | ||
| Dawn Diode Laser System | ||
| (To be decided) | Guilin Woodpecker | |
| D-Laser Blue | ||
| (K210367) | ||
| Product Code | ||
| NVK, GEX, ILY | NVK, GEX, ILY | Same |
| Regulation Number | ||
| 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Classification | ||
| Class II | Class II | Same |
| 450 nm, 635 nm and 980 nm Diode Laser Indication for Use | ||
| • Intended for intra- and extra-oral surgery including incision, | ||
| excision, hemostasis, coagulation and vaporization of soft tissue | ||
| including marginal and inter-dental 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; | 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 inter-dental 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; | Same |
11
Product: Dawn Laser
003_510(k) Summary Version:A/1
| vestibuloplasty; excision of lesions; exposure of |
|---|
| unerupted/partially erupted teeth; removal of hype |
| treatment of aphthous ulcers; leukoplakia; laser r |
| unerupted | unerupted/partially erupted teeth; removal of hyperplastic tissues; |
|---|---|
| treatment | treatment of aphthous ulcers; leukoplakia; laser removal of |
| diseased, | diseased, infected, inflamed and necrosed soft tissue within the |
| periodonta | periodontal pocket; sulcular debridement (removal of diseased, |
| infected, in | infected, inflamed and necrosed soft tissue in the periodontal |
| to improve | pocket to improve clinical indices including gingival index, gingival |
| index, prob | bleeding index, probe depth, attachment loss and tooth inability); |
| pulpotomy | pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma |
| gingival inc | removal; gingival incision and excision; treatment of canker sores; |
| ulcers of th | herpetic ulcers of the oral mucosa; laser soft tissue curettage; |
| gingival hy | reduction of gingival hypertrophy. |
Whitening:
- whitening and for laser-assisted whitening/bleaching of tee Indicated for light activation for bleaching materials for
רן
| Low Level Laser Therapy: | Low Level Laser Therapy: |
|---|---|
| Intended to emit energy in the red and infrared spectrum to | D-Laser Blue and D-Laser 16 are intended to emit energy in the |
| provide topical heating for the purpose of elevating tissue | and infrared spectrum to provide topical heating for the purpose |
| temperature for the temporary relief of minor muscle and joint | elevating tissue temperature for the temporary relief of minor |
| pain and stiffness, minor arthritis pain, or muscle spasm, and for | muscle and joint pain and stiffness, minor arthritis pain, or musc |
| the temporary increase in local blood circulation and/or temporary | spasm, and for the temporary increase in local blood circulation |
| issues; | papillectomy; vestibuloplasty; excision of lesions; exposure of
unerupted/partially erupted teeth; removal of hyperplastic tissues; |
|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| the | treatment of aphthous ulcers; leukoplakia; laser removal of |
| sed, | diseased, infected, inflamed and necrosed soft tissue within the |
| sed | periodontal pocket; sulcular debridement (removal of diseased, |
| tal | infected, inflamed and necrosed soft tissue in the periodontal pocket |
| gingival | to improve clinical indices including gingival index, gingival bleeding
index, probe depth, attachment loss and tooth inability); pulpotomy; |
| oma | pulpotomy as adjunct to root canal therapy; fibroma removal; |
| sores; | gingival incision and excision; treatment of canker sores; herpetic |
| e; | ulcers of the oral mucosa; laser soft tissue curettage; reduction of
gingival hypertrophy. |
| | Whitening: |
| ch. | 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 |
12
003_510(k) Summary
Product: Dawn Laser
Version:A/1
| relaxation of muscles. | and/or temporary relaxation of muscles. | ||
|---|---|---|---|
| Application | Dental Laser | Dental Laser | Same |
| Laser Classification | |||
| 450 nm Laser: Class IV | 450 nm Laser: Class IV | Same | |
| 635 nm Laser: Class II | 650 nm Laser: Class II | Different but acceptable as | |
| Reference Device K071687: IQ 630- |
-
| |
| 980 nm Laser: Class IV | 976 nm Laser: Class IV | Different but same as Reference
Device K163128 : 980nm | |
| Laser Type | | | |
| Solid state diode | Solid state diode | Same | |
| Laser Wavelength | | | |
| 450 nm (+/-20 nm)
(430-470) | 450 nm (+/-20 nm)
(430-470) | Same | |
| 635 nm (+/-20 nm)
(615-655) | 650 nm (+/-20 nm)
(630-670) | Different but same as Reference
Device K111643 : 635nm ((+/-20 nm)
or 615nm-655nm | |
| 80 nm (+/-20 nm)
(960-1000) | 976 nm (+/-20 nm)
(956-996) | Different but same as Reference
Device K163128 : 980 nm (+/-20 nm
or 960-1000 nm | |
| Optical Power | | | |
| 450 nm:
1.1 W - 4 W (Continuous Wave) | 450 nm:
0.2 W - 3.0 W (Continuous Wave)
4 W (peak power) | Different but acceptable as
Reference Device K202291 : 445nm:
Up to 4W | |
| 635 nm:
10 mW - 300 mW (Continuous Wave) | 650 nm:
25 mW - 200 mW (Continuous Wave) | Different but acceptable as
Reference Device K071687: IQ 630-
670: ≤ 5W | |
| 980 nm:
1.1 W - 8 W (Continuous Wave) | 976 nm:
0.2 W - 4 W (Continuous Wave)
7 W (peak power) | Different but acceptable as
Reference Device K202291 : 980nm:
Up to 12W | |
| Emission Modalities | | | |
| Continuous Wave
Chopped (up to 20 kHz) | • Continuous Wave
• Chopped (1 Hz - 20 kHz) | Different but acceptable as
Reference Device K163128: Up to 20 kHz (20,000 Hz). | |
| Pulse Duration | | | |
| Chopped Mode:
10 µsec - 9.9 sec. | Chopped Mode:
5 µsec To 0.9 sec. | Different but acceptable as
Reference Device K163128 : 0.01-
100ms (10 µ sec-100ms) and
Reference Device K202991: 0.1ms-60s. | |
| Aiming Beam | | | |
13
003_510(k) Summary
Product: Dawn Laser
Version:A/1
14
003_510(k) Summary
| 635±20 nm
Pmax |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| tissue within the periodontal pocket
• Cosmetic Dentistry;
• Laser-assisted bleaching/whitening of the teeth
• Light activation for bleaching materials for teeth whitening
• Implant recovery | 810 nm Diode Laser in therapy:
• Temporary relief of minor muscle and joint pain and stiffness,
minor arthritis pain, or muscle spasm, minor sprains and
strains, and minor muscular back pain; the temporary increase in
local blood circulation; the temporary relaxation of muscle. | Similar, and same as the Predicate
Device K210367: D-Laser Blue |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| tissue within the periodontal pocket
• Cosmetic Dentistry;
• Laser-assisted bleaching/whitening of the teeth
• Light activation for bleaching materials for teeth whitening
• Implant recovery | 980 nm Diode Laser Indication for Use
• Intended for intra- and extra-oral surgery including incision,
excision, hemostasis, coagulation and vaporization of soft tissue
including marginal and inter-dental 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 tooth: removal of hyperplastic tissues: treatment of | |
| | 980 nm Diode Laser in dentistry:
• Surgical applications requiring the ablation, vaporization,
excision, incision, hemostasis, or coagulation of soft tissues in
medical specialties including dermatology, dentistry,
gastroenterology, general surgery, genitourinary, gynecology,
neurosurgery, otolaryngology, orthopedics, ophthalmology,
pulmonology and thoracic surgery
• Gingival troughing
• Crown lengthening
• Gingivoplasty
• Coagulation | |
18
Product: Dawn Laser
003_510(k) Summary Version:A/1
| aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, infected, 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. | Implant uncovery Implant recovery Soft tissue curettage Sulcular debridement Biopsy Frenectomy Hemostasis of donor site Operculectomy Exposure of unerupted teeth Pulpotomy Treatment of aphthous ulcers Excision of lesions Light activation of bleaching materials for teeth whitening |
|---|---|
| Whitening: | |
| • Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. | |
| Low Level Laser Therapy: | |
| • 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. |
19
Product: Dawn Laser
Version:A/1 003_510(k) Summary
| 1064 nm Diode Laser in dentistry:
• Excisional and incisional biopsies;
• Excision and vaporization of herpes simplex I and II;
• Frenectomy and frenotomy;
• Gingivectomy;
• Gingivoplasty;
• Gingival incision and excision;
• Hemostasis;
• Implant recovery;
• Operculectomy;
• Pulpotomy and pulpotomy as an adjunct to root canal therapy;
• Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
• Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility);
• Treatment of aphthous ulcers and herpetic lesions | 1064 nm Diode Laser in dentistry:
• Excisional and incisional biopsies;
• Excision and vaporization of herpes simplex I and II;
• Frenectomy and frenotomy;
• Gingivectomy;
• Gingivoplasty;
• Gingival incision and excision;
• Hemostasis;
• Implant recovery;
• Operculectomy;
• Pulpotomy and pulpotomy as an adjunct to root canal therapy;
• Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
• Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility);
• Treatment of aphthous ulcers and herpetic lesions | Same |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | 1064 nm Diode Laser in dermatology and other surgical areas:
• General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs | |
20
Product: Dawn Laser
003_510(k) Summary
Version:A/1
| and glands, fibroma removal;
• Podiatry (ablation, vaporization, incision, excision, and coagulation
of soft tissue) including: Matrixectomy, Periungual and subungual
warts, Plantar warts, Radical nail excision, Neuromas.
• Temporary increase of clear nail in patients with onychomycosis
(e.g. dermatophytes Trichophyton rubrum and T mentagrophytes
and/or yeasts Candida albicans, etc.);
1064 nm Diode Laser in therapy
• Temporary relief of muscle and joint pain and stiffness, arthritis
pain or muscle spasm, temporary increase in local blood
| circulation and/or promoting relaxation of muscle. | ||
|---|---|---|
| Engergy source | ||
| Solid State Diode | Solid State Diode | Same |
| Wavelength | ||
| 810 nm | 810 nm | Same |
| 980 nm | 980 nm | Same |
| 1064 nm | 1064 nm | Same |
| Aiming beam | ||
| 810 nm: | 810 nm: | Different but acceptable as |
| Laser diode 635 nm (red); 980 nm: | ||
| Laser diode 635 nm (red); 980 nm: | ||
| Laser diode 532 nm (green); 1064 nm: | ||
| Laser diode 635 nm (red); 1064 nm: | ||
| Laser diode 532 nm (green); 810 nm: | ||
| 0.1 W - 8 W (optional) | 810 nm: | |
| Up to 8 W | Same | |
| 980 nm: | ||
| 0.1 W - 8 W | 980 nm: | |
| Up to 12 W | Same | |
| 1064 nm: | ||
| 0.1 W - 10 W | 1064 nm: | |
| Up to 10 W | Same | |
| Pulse width | ||
| 810 nm: | ||
| 10 μs - 9.9 s/CW | 810 nm: | |
| 0.1 ms - 45 s/CW | Different but acceptable as | |
| Reference Device K163128: 0.01- | ||
| 100ms (10 μ sec-100ms) and | ||
| Reference Device K202991: 0.1ms- | ||
| 60s. | ||
| 980 nm: | ||
| 10 μs - 9.9 s/CW | 980 nm: | |
| 0.1 ms - 45 s/CW | Different but acceptable as | |
| Reference Device K163128: 0.01- | ||
| 100ms (10 μ sec-100ms) and | ||
| Reference Device K202991: 0.1ms- | ||
| 1064 nm: | ||
| 10 µs - 9.9 s/CW | 1064 nm: | |
| 0.1 ms - 45 s/CW | 60s. | |
| Different but acceptable as | ||
| Reference Device K163128: 0.01- | ||
| 100ms (10 µ sec-100ms) and | ||
| Reference Device K202991: 0.1ms- | ||
| 60s. | ||
| Repetition rate | ||
| 810 nm: | ||
| Up to 20 kHz/CW | 810 nm: | |
| Up to 200 Hz/CW | Different but acceptable as | |
| Reference Device K163128: Up to | ||
| 20 kHz (20,000 Hz). | ||
| 980 nm: | ||
| Up to 20 kHz/CW | 980 nm: | |
| Up to 200 Hz/CW | Different but acceptable as | |
| Reference Device K163128: Up to | ||
| 20 kHz (20,000 Hz). | ||
| 1064 nm: | ||
| Up to 20 kHz/CW | 1064 nm: | |
| Up to 200 Hz/CW | Different but acceptable as | |
| Reference Device K163128: Up to | ||
| 20 kHz (20,000 Hz). | ||
| Delivery system | ||
| 810 nm: | ||
| Contact and non-contact handpieces connected to the system via | ||
| fiber delivery | 810 nm: | |
| Contact and non-contact handpieces connected to the system via | ||
| fiber delivery | Same | |
| 980 nm: | ||
| Contact and non-contact handpieces connected to the system via | ||
| fiber delivery | 980 nm: | |
| Contact and non-contact handpieces connected to the system via | ||
| fiber delivery | Same | |
| 1064 nm: | ||
| Contact and non-contact handpieces connected to the system via | ||
| fiber delivery | Same | |
| User interface | Contact and non-contact handpieces connected to the system via | |
| fiber delivery | Same | |
| 810 nm: | ||
| Touch screen control | 810 nm: | |
| Touch screen control | Same | |
| 980 nm: | ||
| Touch screen control | 980 nm: | |
| Touch screen control | Same | |
| 1064 nm: | ||
| Touch screen control | 1064 nm: | |
| Touch screen control | Same |
22
003_510(k) Summary
Product: Dawn Laser
Version:A/1
23
003_510(k) Summary
Product: Dawn Lase
Version:A/1
System Family (XPulse 1064 nm, XPulse 980 nm) have the same indications for use respectively. Although there are subt echnological characteristic differences between the predicate devices, it is clear that the technological characterist om above two tables, the proposed device Dawn Diode Laser System and the predicate devices D-Laser Blue and Fotona XPulse differences discussed do not affect the substantial equivalenc
24
5.7 Brief discussion of the non-clinical tests
To verify the performance requirements of Dawn Diode Laser System, the following tests were performed. It shows that the testing results do support substantial equivalence.
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices
EC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-9 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design
ISO 17664-1 First edition 2021-07 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
25
Version:A/0
Product: Dawn Laser
Summarize studies conducted utilizing Dawn comparing the cutting efficiency of the predicate devices.
5.8 Brief discussion of clinical tests
No human clinical data is needed for Dawn Diode Laser System.
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, Shanghai Wonderful Opto-Electrics Tech Co., Ltd. concludes that:
- The indications for use of Dawn Diode Laser System are totally same as those of the . predicate devices.
- The technological characteristic differences between Dawn Diode Laser System and the . predicate devices do not affect the substantial equivalence, so no new risk is raised.
- Demonstrated by the safety and performance tests, the characteristics of Dawn Diode Laser . System are respectively equivalent to those of the predicate devices.