Medical Diode Laser Systems

K230047 · Gigaalaser Company , Ltd. · NVK · Mar 4, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K230047
• Device Name: Medical Diode Laser Systems
• Applicant: Gigaalaser Company , Ltd.
• Product Code: NVK · General, Plastic Surgery
• Decision Date: Mar 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Medical Diode Laser Systems 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; papillectorny; 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: Medical Diode Laser Systems are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: Medical Diode Laser Systems are intended 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.

Device Story

Compact, air-cooled, battery-powered diode laser system; utilizes GaAlAs semiconductor diodes to convert electric energy into coherent laser radiation (810nm or 980nm wavelengths; 650nm pilot beam). Operated by dental professionals in clinical settings via color touch screen interface and foot switch. System features microprocessor-controlled adjustable light output with automatic power stabilization. Laser energy delivered via fiber optic cable, handpiece, and fiber tips for soft tissue procedures, teeth whitening, or topical heating. Benefits include precise soft tissue management, hemostasis, and non-invasive pain relief. Device includes safety features, high-capacity fans for cooling, and replaceable laser modules.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), laser safety (IEC 60825-1), and performance testing (IEC 60601-2-22).

Technological Characteristics

GaAlAs semiconductor diode laser; 810nm/980nm wavelengths; 0.1W-20W output power; air-cooled; fiber optic delivery; microprocessor-controlled; lithium battery-powered; Class IV laser; color touch screen interface; foot switch activation.

Indications for Use

Indicated for dental patients requiring soft tissue surgery (incision, excision, hemostasis, coagulation, vaporization), teeth whitening, or low-level laser therapy for topical heating to relieve minor muscle/joint pain, stiffness, or muscle spasm and increase local blood circulation.

Regulatory Classification

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.

Predicate Devices

• D-Laser Blue, D-Laser 16 (K210367)

Reference Devices

• Gemini 810+980 Diode Laser (K192617)

Submission Summary (Full Text)

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March 4, 2024

Gigaalaser Company Ltd. Xinxing Nie Regulations Control Manager 304, 306, 3F No.3 plant, Building B10 Wuhan Hi-Tech Medical Device Industrial Park Wuhan, Hubei 430206 CHINA

Re: K230047

Trade/Device Name: Medical Diode Laser Systems 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: NVL, GEX, ILY, EEG Dated: February 2, 2024 Received: February 2, 2024

Dear Xinxing Nie:

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 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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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 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).

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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

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### Indications for Use

510(k) Number (if known) K230047

Device Name Medical Diode Laser Systems

#### Indications for Use (Describe)

Medical Diode Laser Systems 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; biopsy; operculectomy; implant recovery; gingivoplasty; 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;papillectorny; 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: Medical Diode Laser Systems are indicated for light activation materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: Medical Diode Laser Systems are intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffins 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) | |
|-------------------------------------------------|-----------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> |

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## Section 5 510(k) summary

K230047

#### l Submitter

- Device submitter: Gigaalaser Company Ltd. Add.: 304, 306, 3F No.3 plant, Building B10, Wuhan Hi-Tech Medical Device Industrial Park, #818 Gaoxin Avenue, East Lake Development Zone, Wuhan,China (Free Trade Zone Wuhan Area)
- Contact person: Xinxing Nie Title: Regulations Control Manager Phone: [phone] Fax: [phone] Email: [e-mail]

#### II Device

| Trade Name of Device: | Medical Diode Laser Systems |
|--------------------------|----------------------------------------------------------------------------------------|
| Common name: | Dental diode laser |
| Classification name: | Laser Surgical Instrument for Use in General and<br>Plastic Surgery and in Dermatology |
| Classification: | Class II, 21 CFR 878.4810 |
| Primary Product Code: | NVK |
| Secondary Product Codes: | GEX, ILY |
| Review Panel: | General & Plastic Surgery |
| Submission number: | Unknown |

#### III Predicate Device and Reference Device

| Primary Predicate Device | |
|--------------------------|------------------------------------------------------------------|
| Trade name: | D-Laser Blue, D-Laser 16 |
| Common name: | Dental Diode Lasers |
| Regulation number: | 21 CFR 878.4810 |
| Classification | Laser Surgical Instrument for Use in General and Plastic Surgery |
| Name: | and in Dermatology |
| Requlatory class: | Class II |
| Product code: | NVK, GEX, ILY |
| Submitter: | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 510(k) number: | K210367 |

Reference Predicate Device Gemini 810+980 Diode Laser Trade name:

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| Common name: | Powered laser surgical instrument, Infrared lamp |
|-------------------------|-----------------------------------------------------------------------------------------------------------|
| Regulation number: | 21 CFR 878.4810 |
| Classification<br>Name: | Laser Surgical Instrument for Use in General and Plastic Surgery<br>and in Dermatology; and infrared lamp |
| Regulatory class: | Class II |
| Product code: | GEX, ILY |
| Submitter: | Azena Medical, LLC |
| 510(k) number: | K192617 |

#### IV Device description

The Medical Diode Laser System is a compact, air-cooled unit. It is a complete self-contained instrument, which includes a high efficiency power supply, a microprocessor controlled, adjustable light output with automatic power stabilization, (fan cooled), as well as a switch panel and LCD screen display panel designed to be user friendly. The system includes high power lasers, safety features and an SMA fiber output connector. The system includes a Lithium battery, it can work 1hour when not external power input at maximum power output in pulse or CW but intermittent mode. The diodes are made from GaAlAs semiconductor material for high output and superior reliability. The diode lasers are enclosed in a rugged, factory-aligned, replaceable, environmentally protective module. High-capacity fans eliminate the need for water-cooling, and assure low maintenance and reliable laser operation. The diodes convert electric energy into coherent laser radiation with a wavelength of 810nm or 980nm+/-10nm (pilot beam: 650nm+/-10nm).

| Product | Model | Output power | Laser Wavelength |
|-----------------------------------|--------------|------------------------------|--------------------|
| Medical<br>Diode Laser<br>Systems | DEN7A | 0.1W-7W (±20%) | 810nm±10nm |
| | DEN7B | 0.1W-7W (±20%) | 980nm±10nm |
| | DEN10B | 0.1W-10W (±20%) | 980nm±10nm |
| | CHEESEII-7A | 0.1W-7W (±20%) | 810nm±10nm |
| | CHEESEII-7B | 0.1W-7W (±20%) | 980nm±10nm |
| | CHEESEII-10B | 0.1W-10W (±20%) | 980nm±10nm |
| | GBOX-20B | 1-20W (±10%) | 980nm±10nm |
| | GBOX-15A | 1-15W (±10%) | 810nm±10nm |
| | GBOX-15B | 1-15W (±10%) | 980nm±10nm |
| | GBOX-15AB | 810nm/980nm: 1-15W<br>(±10%) | 810nm±10nm |
| | | 980nm±10nm | |
| | | 810nm+980nm: 1W-15W | 810nm+980nm(±10nm) |

The product is divided into 10 models according to wavelength and output power:

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| | | (±10%) | | |
|--|--|--------|--|--|
|--|--|--------|--|--|

#### V Indications for use

Medical Diode Laser Systems 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; papillectorny; 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: Medical Diode Laser Systems are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: Medical Diode Laser Systems are intended 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.

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#### VI Comparison of technological characteristics with the predicate devices

The Medical Diode Laser System has the same intended use and principal operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Medical Diode Laser System and predicate devices do not alter suitability of the proposed device for its intended use.

| Item | Proposed device | Predicate device<br>(K210367) | Reference device<br>(K192617) | Discussion |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Code | Medical Diode Laser Systems<br>NVK, GEX, ILY | D-Laser Blue, D-Laser 16<br>NVK, GEX, ILY | Gemini 810+980 Diode Laser<br>GEX, ILY | Identical |
| Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Classificati<br>on | Class II | Class II | Class II | Identical |
| Indication<br>for Use | Medical Diode Laser Systems are<br>intended for intra- and extra-oral<br>surgery including incision, excision,<br>hemostasis, coagulation and<br>vaporization of soft tissue including<br>marginal and inter-dental and<br>epithelial lining of free gingiva and<br>are indicated for: frenectomy;<br>frenotomy; biopsy; operculectomy;<br>implant recovery; gingivectomy;<br>gingivoplasty; gingival troughing;<br>crown lengthening; hemostasis of<br>donor site: removal of granulation | D-Laser Blue and D-Laser 16 are<br>intended for intra- and extra-oral<br>surgery including incision, excision,<br>hemostasis, coagulation and<br>vaporization of soft tissue including<br>marginal and interdental and<br>epithelial lining of free gingiva and<br>are indicated for: frenectomy;<br>frenotomy; biopsy; operculectomy;<br>implant recovery; gingivectomy;<br>gingivoplasty; gingival troughing;<br>crown lengthening; hemostasis of<br>donor site: removal of granulation | Dental Soft Tissue Indications:<br>Incision, excision, vaporization,<br>ablation and coagulation of oral soft<br>tissues including marginal and<br>inter-dental gingival and epithelial<br>lining of free gingiva and the<br>following specific indications:<br>• Excisional and incisional biopsies<br>• Exposure of unerupted teeth<br>• Fibroma removal<br>• Frenectomy<br>• Frenotomy<br>• Gingival troughing for crown | Substantial<br>Equivalence<br><br>The<br>reference<br>device does<br>not have the<br>intended use<br>for light<br>activation for<br>bleaching<br>materials for<br>teeth |
| Item | Proposed device | Predicate device<br>(K210367) | Reference device<br>(K192617) | Discussion |
| | Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | |
| | tissue; laser assisted flap<br>surgery;debridement of diseased<br>epithelial lining; incisions and<br>draining of abscesses; tissue<br>retraction for impressions;<br>papillectomy; vestibuloplasty ;<br>excision of lesions; exposure of<br>unerupted/partially erupted teeth;<br>removal of hyperplastic tissues;<br>treatment of aphthous ulcers;<br>leukoplakia; laser removal of<br>diseased, infected, inflamed and<br>necrosed soft tissue within the<br>periodontal pocket; sulcular<br>debridement (removal of diseased,<br>infected, inflamed and necrosed soft<br>tissue in the periodontal pocket to<br>improve clinical indices including<br>gingival index, gingival bleeding<br>index, probe depth, attachment loss<br>and tooth inability); pulpotomy;<br>pulpotomy as adjunct to root canal<br>therapy; fibroma removal; gingival | tissue; laser assisted flap surgery;<br>debridement of diseased epithelial<br>lining; incisions and draining of<br>abscesses; tissue retraction for<br>impressions; papillectomy;<br>vestibuloplasty; excision of lesions;<br>exposure of unerupted/partially<br>erupted teeth; removal of<br>hyperplastic tissues; treatment of<br>aphthous ulcers; leukoplakia; laser<br>removal of diseased, infected,<br>inflamed and necrosed soft tissue<br>within the periodontal pocket;<br>sulcular debridement (removal of<br>diseased, infected, inflamed and<br>necrosed soft tissue in the<br>periodontal pocket to improve clinical<br>indices including gingival index,<br>gingival bleeding index, probe depth,<br>attachment loss and tooth inability);<br>pulpotomy; pulpotomy as adjunct to<br>root canal therapy; fibroma removal;<br>gingival incision and excision; | impressions<br>• Gingivectomy<br>• Gingivoplasty<br>• Gingival incision and excision<br>• Hemostasis and coagulation<br>• Implant recovery<br>• Incision and drainage of abscess<br>• Leukoplakia<br>• Operculectomy<br>• Oral papillectomies<br>• Pulpotomy<br>• Pulpotomy as an adjunct to root<br>canal therapy<br>• Reduction of gingival hypertrophy<br>• Soft tissue crown lengthening<br>• Treatment of canker sores,<br>herpetic and aphthous ulcers of the<br>oral mucosa<br>• Treatment of aphthous ulcers.<br>• Vestibuloplasty<br>• Tissue retraction for impression<br>• Lesion (tumor) removal<br>Laser Periodontal Procedures | whitening<br>and<br>for<br>laser-assiste<br>d<br>whitening/ble<br>aching of<br>teeth. While<br>the intended<br>use of<br>proposed<br>device is<br>same as the<br>predicated<br>device<br>(K210367),<br>this<br>difference<br>does not<br>affect the<br>safety and<br>effectiveness. |
| Item | Proposed device | Predicate device<br>(K210367) | Reference device<br>(K192617) | Discussion |
| | Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | |
| | incision and excision; treatment of<br>canker sores; herpetic ulcers of the<br>oral mucosa; laser soft tissue<br>curettage; reduction of gingival<br>hypertrophy. | treatment of canker sores; herpetic<br>ulcers of the oral mucosa; laser soft<br>tissue curettage; reduction of gingival<br>hypertrophy. | • Laser soft tissue curettage.<br>• Laser removal of diseased,<br>Infected, Inflamed and necrosed soft<br>tissue within the periodontal pocket.<br>• Removal of highly inflamed<br>edematous tissue affected by<br>bacteria penetration of the pocket<br>lining and junctional epithelium.<br>• Sulcular debridement (removal of<br>diseased, infected, inflamed and<br>necrosed soft tissue in the<br>periodontal pocket to improve clinical<br>indices including gingival index,<br>gingival bleeding index, probe depth,<br>attachment loss and tooth mobility)<br>• Reduction of bacterial level<br>(decontamination) and inflammation | |
| | Whitening: Medical Diode Laser<br>Systems are indicated for light<br>activation for bleaching materials for<br>teeth whitening and for laser-assisted<br>whitening/bleaching of teeth. | Whitening: D-Laser Blue and<br>D-Laser 16 are indicated for light<br>activation for bleaching materials for<br>teeth whitening and for laser-assisted<br>whitening/bleaching of teeth. | NA | |
| | Low Level Laser Therapy: Medical | Low Level Laser Therapy: D-Laser | Pain therapy: | |
| Item | Proposed device | Predicate device<br>(K210367) | Reference device<br>(K192617) | Discussion |
| | Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | |
| | Diode Laser Systems are intended to<br>provide topical heating for the<br>purpose of elevating tissue<br>temperature for the temporary relief<br>of minor muscle and joint pain and<br>stiffness, minor arthritis pain, or<br>muscle spasm, and for the temporary<br>increase in local blood circulation<br>and/or temporary relaxation of<br>muscles. | Blue and D-Laser 16 are intended to<br>emit energy in the red and infrared<br>spectrum to provide topical heating<br>for the purpose of elevating tissue<br>temperature for the temporary relief<br>of minor muscle and joint pain and<br>stiffness, minor arthritis pain, or<br>muscle spasm, and for the temporary<br>increase in local blood circulation<br>and/or temporary relaxation of<br>muscles. | • Topical heating for the purpose of<br>elevating tissue temperature for a<br>temporary relief of minor muscle and<br>joint pain and stiffness, minor arthritis<br>pain, or muscle spasm, minor sprains<br>and strains, and minor muscular back<br>pain, the temporary increase in local<br>blood circulation; the temporary<br>relaxation of muscle. | |
| Application | Dental Laser | Dental Laser | Dental Laser | Identical |
| Laser<br>Classification | Class IV | 976 nm and 450nm: Laser: Class IV<br>650 nm Laser: Class II | Class IV | Substantial<br>Equivalence |
| Type of<br>Laser | Diode Laser | Diode Laser | Diode Laser | Identical |
| Wavelength | 810 ± 10nm;<br>980 ± 10nm; | 976 nm (+/-20 nm);<br>650 nm (+/-20 nm);<br>450 nm (+/-20 nm); | 810 ± 10nm;<br>or 980 ± 10nm;<br>or 810nm and 980nm ± 10nm | Substantial<br>Equivalence<br>According to<br>K192617, the<br>modification |
| Item | Proposed device | Predicate device<br>(K210367) | Reference device<br>(K192617) | Discussion |
| | Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | |
| | | |…