(423 days)
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.
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).
This document is a 510(k) premarket notification for a medical device (Medical Diode Laser Systems) and explicitly states that no clinical testing was performed. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully answered as it pertains to clinical performance and AI integration.
The provided document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical testing (electrical safety, EMC, laser safety standards, and software verification). There is no mention of AI/ML, human-in-the-loop performance studies, or ground truth establishment based on expert consensus, pathology, or outcomes data, which are typical requirements for AI/ML device clearances.
Based on the provided text, here's what can be inferred/extracted and what cannot be answered:
1. Table of acceptance criteria and the reported device performance:
Since no clinical or AI performance study was presented, the "acceptance criteria" here refer to conformance with established safety and performance standards for laser medical devices.
| Acceptance Criteria (from Non-Clinical Tests) | Reported Device Performance (Compliance) |
|---|---|
| Conformity to IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | Verified |
| Conformity to IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility) | Verified |
| Conformity to IEC 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements) | Verified |
| Performance 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). | Verified |
| Software Verification and Validation (for "moderate" level of concern) as per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Conducted and documentation provided. |
| Device Specifications (Comparison to predicate, serving as a form of "performance" for equivalence) | (All stated as "Identical" or "Substantial Equivalence" to predicate/reference devices) |
| Product Code (NVK, GEX, ILY) | Identical (to predicate K210367) |
| Regulation Number (21 CFR 878.4810) | Identical |
| Classification (Class II) | Identical |
| Indications for Use | Substantial Equivalence (Proposed device's intended use is same as predicate; reference device does not have light activation for bleaching materials for teeth whitening, but this difference does not affect safety and effectiveness based on the submission.) |
| Application (Dental Laser) | Identical |
| Laser Classification (Class IV) | Substantial Equivalence (Predicate states 976nm and 450nm: Class IV, 650nm: Class II; Reference states Class IV). The document implies this is an acceptable difference for substantial equivalence. |
| Type of Laser (Diode Laser) | Identical |
| Wavelength (810 ± 10nm; 980 ± 10nm) | Substantial Equivalence (Predicate: 976nm, 650nm, 450nm; Reference: 810nm, 980nm). Stated that modification (different wavelengths) does not adversely affect safety and effectiveness. |
| Average Power (Range specific to models) | Similar to predicate/reference device. Example: Proposed DEN7A/DEN7B: 0.1W-7W vs. Predicate D-Laser Blue 976nm: 0.2W-4W (CW), 7W (peak). Reference: 0.1-2W, 20W (peak). The ranges for the proposed device generally align with or explain differences within the scope of the predicate devices. |
| Operation Mode (Continuous Wave; Pulse) | Identical to the predicate. |
| Pulse width (e.g., 1ms-1000ms for DEN models) | Similar (Predicate: 5 µsec. to 0.9 sec.; Reference: Variable). |
| Pulse repetition rate (e.g., 0.5Hz-500Hz for DEN models) | Similar (Predicate: 1 Hz—20 kHz; Reference: 50Hz). |
| Aiming Beam (650±10 nm, 5mw (max)) | Substantial Equivalence (Predicate: 650±20 nm, Pmax<5 mW; Reference: 5mW laser diode, 650nm, Class 1). |
| Delivery system (Fiber optic cable, handpiece and fiber tips) | Substantial Equivalence (Proposed: 200µm, 400µm, 600µm and 800µm fibers; Predicate: 200µm, 300µm, 400µm; Reference: 400µm). Differences in fiber sizes are considered substantially equivalent. |
| Operation interface (Color touch screen graphical user interface) | Substantial Equivalence (Predicate: Color touch screen graphical user interface; Reference: Electroluminescent glass display with capacitive touch interface). Considered substantially equivalent. |
| Activation Means (Foot Switch, with electronic access key) | Substantial Equivalence (Predicate: Handpiece finger switch, Wireless foot switch; Reference: Wireless Foot Switch, with electronic access key). Differences in activation methods are considered substantially equivalent. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided for AI/ML performance testing. The document refers to non-clinical tests on the device itself.
- Data Provenance: Not applicable for AI/ML performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as no AI/ML clinical performance study requiring expert ground truth was conducted. For device testing, compliance with standards is the "ground truth" and is assessed by qualified test engineers/labs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no AI/ML clinical performance study requiring adjudication was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Testing: It is not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone AI algorithm performance study was not done. The device is a physical laser system, not an AI algorithm for diagnostic or therapeutic assistance. The "Software Verification and Validation" mentioned pertains to the embedded software controlling the laser, not a separate AI model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" is compliance with international and national recognized standards (e.g., IEC 60601-1, IEC 60825-1) and internal design specifications, verified through laboratory testing. There is no clinical or AI-related ground truth as defined in the prompt.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device submission for which a training set would be described.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device submission.
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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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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Section 5 510(k) summary
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: +86-27-18086025718 Fax: +86-27-6784 8873 Email: fdagigaalaser@sohu.com
II Device
| Trade Name of Device: | Medical Diode Laser Systems |
|---|---|
| Common name: | Dental diode laser |
| Classification name: | Laser Surgical Instrument for Use in General andPlastic 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 |
| ClassificationName: | Laser Surgical Instrument for Use in General and Plastic Surgeryand 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 |
|---|---|---|---|
| MedicalDiode LaserSystems | 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(±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(K210367) | Reference device(K192617) | Discussion |
|---|---|---|---|---|
| ProductCode | Medical Diode Laser SystemsNVK, GEX, ILY | D-Laser Blue, D-Laser 16NVK, GEX, ILY | Gemini 810+980 Diode LaserGEX, ILY | Identical |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Indicationfor Use | Medical Diode Laser Systems areintended for intra- and extra-oralsurgery including incision, excision,hemostasis, coagulation andvaporization of soft tissue includingmarginal and inter-dental andepithelial lining of free gingiva andare indicated for: frenectomy;frenotomy; biopsy; operculectomy;implant recovery; gingivectomy;gingivoplasty; gingival troughing;crown lengthening; hemostasis ofdonor site: removal of granulation | D-Laser Blue and D-Laser 16 areintended for intra- and extra-oralsurgery including incision, excision,hemostasis, coagulation andvaporization of soft tissue includingmarginal and interdental andepithelial lining of free gingiva andare indicated for: frenectomy;frenotomy; biopsy; operculectomy;implant recovery; gingivectomy;gingivoplasty; gingival troughing;crown lengthening; hemostasis ofdonor site: removal of granulation | Dental Soft Tissue Indications:Incision, excision, vaporization,ablation and coagulation of oral softtissues including marginal andinter-dental gingival and epitheliallining of free gingiva and thefollowing specific indications:• Excisional and incisional biopsies• Exposure of unerupted teeth• Fibroma removal• Frenectomy• Frenotomy• Gingival troughing for crown | SubstantialEquivalenceThereferencedevice doesnot have theintended usefor lightactivation forbleachingmaterials forteeth |
| Item | Proposed device | Predicate device(K210367) | Reference device(K192617) | Discussion |
| Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | ||
| tissue; laser assisted flapsurgery;debridement of diseasedepithelial lining; incisions anddraining of abscesses; tissueretraction for impressions;papillectomy; vestibuloplasty ;excision of lesions; exposure ofunerupted/partially erupted teeth;removal of hyperplastic tissues;treatment of aphthous ulcers;leukoplakia; laser removal ofdiseased, infected, inflamed andnecrosed soft tissue within theperiodontal pocket; sulculardebridement (removal of diseased,infected, inflamed and necrosed softtissue in the periodontal pocket toimprove clinical indices includinggingival index, gingival bleedingindex, probe depth, attachment lossand tooth inability); pulpotomy;pulpotomy as adjunct to root canaltherapy; fibroma removal; gingival | tissue; laser assisted flap surgery;debridement of diseased epitheliallining; incisions and draining ofabscesses; tissue retraction forimpressions; papillectomy;vestibuloplasty; excision of lesions;exposure of unerupted/partiallyerupted teeth; removal ofhyperplastic tissues; treatment ofaphthous ulcers; leukoplakia; laserremoval of diseased, infected,inflamed and necrosed soft tissuewithin the periodontal pocket;sulcular debridement (removal ofdiseased, infected, inflamed andnecrosed soft tissue in theperiodontal pocket to improve clinicalindices including gingival index,gingival bleeding index, probe depth,attachment loss and tooth inability);pulpotomy; pulpotomy as adjunct toroot canal therapy; fibroma removal;gingival incision and excision; | impressions• Gingivectomy• Gingivoplasty• Gingival incision and excision• Hemostasis and coagulation• Implant recovery• Incision and drainage of abscess• Leukoplakia• Operculectomy• Oral papillectomies• Pulpotomy• Pulpotomy as an adjunct to rootcanal therapy• Reduction of gingival hypertrophy• Soft tissue crown lengthening• Treatment of canker sores,herpetic and aphthous ulcers of theoral mucosa• Treatment of aphthous ulcers.• Vestibuloplasty• Tissue retraction for impression• Lesion (tumor) removalLaser Periodontal Procedures | whiteningandforlaser-assistedwhitening/bleaching ofteeth. Whilethe intendeduse ofproposeddevice issame as thepredicateddevice(K210367),thisdifferencedoes notaffect thesafety andeffectiveness. | |
| Item | Proposed device | Predicate device(K210367) | Reference device(K192617) | Discussion |
| Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | ||
| incision and excision; treatment ofcanker sores; herpetic ulcers of theoral mucosa; laser soft tissuecurettage; reduction of gingivalhypertrophy. | treatment of canker sores; herpeticulcers of the oral mucosa; laser softtissue curettage; reduction of gingivalhypertrophy. | • Laser soft tissue curettage.• Laser removal of diseased,Infected, Inflamed and necrosed softtissue within the periodontal pocket.• Removal of highly inflamededematous tissue affected bybacteria penetration of the pocketlining and junctional epithelium.• Sulcular debridement (removal ofdiseased, infected, inflamed andnecrosed soft tissue in theperiodontal pocket to improve clinicalindices including gingival index,gingival bleeding index, probe depth,attachment loss and tooth mobility)• Reduction of bacterial level(decontamination) and inflammation | ||
| Whitening: Medical Diode LaserSystems are indicated for lightactivation for bleaching materials forteeth whitening and for laser-assistedwhitening/bleaching of teeth. | Whitening: D-Laser Blue andD-Laser 16 are indicated for lightactivation for bleaching materials forteeth whitening and for laser-assistedwhitening/bleaching of teeth. | NA | ||
| Low Level Laser Therapy: Medical | Low Level Laser Therapy: D-Laser | Pain therapy: | ||
| Item | Proposed device | Predicate device(K210367) | Reference device(K192617) | Discussion |
| Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | ||
| Diode Laser Systems are intended toprovide topical heating for thepurpose of elevating tissuetemperature for the temporary reliefof minor muscle and joint pain andstiffness, minor arthritis pain, ormuscle spasm, and for the temporaryincrease in local blood circulationand/or temporary relaxation ofmuscles. | Blue and D-Laser 16 are intended toemit energy in the red and infraredspectrum to provide topical heatingfor the purpose of elevating tissuetemperature for the temporary reliefof minor muscle and joint pain andstiffness, minor arthritis pain, ormuscle spasm, and for the temporaryincrease in local blood circulationand/or temporary relaxation ofmuscles. | • Topical heating for the purpose ofelevating tissue temperature for atemporary relief of minor muscle andjoint pain and stiffness, minor arthritispain, or muscle spasm, minor sprainsand strains, and minor muscular backpain, the temporary increase in localblood circulation; the temporaryrelaxation of muscle. | ||
| Application | Dental Laser | Dental Laser | Dental Laser | Identical |
| LaserClassification | Class IV | 976 nm and 450nm: Laser: Class IV650 nm Laser: Class II | Class IV | SubstantialEquivalence |
| Type ofLaser | Diode Laser | Diode Laser | Diode Laser | Identical |
| Wavelength | 810 ± 10nm;980 ± 10nm; | 976 nm (+/-20 nm);650 nm (+/-20 nm);450 nm (+/-20 nm); | 810 ± 10nm;or 980 ± 10nm;or 810nm and 980nm ± 10nm | SubstantialEquivalenceAccording toK192617, themodification |
| Item | Proposed device | Predicate device(K210367) | Reference device(K192617) | Discussion |
| Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | ||
| does notadverselyaffect safetyandeffectiveness | ||||
| AveragePower | DEN7A/DEN7B: 0.1W-7W;DEN10B: 0.1W-10W; | D-Laser Blue 976nm:0.2 W – 4 W (Continuous Wave)7 W (peak power);D-Laser 16 976nm: | 0.1-2W; 20W (peak power) | Similar as thepredatedevice. |
| 0.3 W - 7 W (Continuous Wave)16 W (peak power); | ||||
| CHEESEII-7A/7B: 0.1W-7W;CHEESEII-10B: 0.1W-10W; | D-Laser Blue 976nm:0.2 W – 4 W (Continuous Wave)7 W (peak power);D-Laser 16 976nm: | 0.1-2W; 20W (peak power) | Similar as thepredatedevice. | |
| 0.3 W - 7 W (Continuous Wave)16 W (peak power); | ||||
| GBOX-20B: 1-20W;GBOX-15A/15B: 1-15W; | D-Laser Blue 976nm:0.2 W – 4 W (Continuous Wave) | 0.1-2W; 20W (peak power) | Similar as thereference | |
| GBOX-15AB: 1-15W. | 7 W (peak power);D-Laser 16 976nm: | device | ||
| Item | Proposed device | Predicate device(K210367) | Reference device(K192617) | Discussion |
| Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | ||
| 0.3 W - 7 W (Continuous Wave) | ||||
| 16 W (peak power); | ||||
| Operation | Continuous Wave; Pulse | Continuous Wave; Pulse | Pulse | Identical to |
| Mode | the predicate | |||
| Pulse | DEN7A/ DEN7B/DEN10B: | 5 µsec. To 0.9 sec. | Variable | Similar |
| width | 1ms-1000ms; | |||
| CHEESEII-7A/7B/10B: 25µs -10s | ||||
| GBOX-15A/ 15B/ 15AB/20B: 25µs | ||||
| -10s | ||||
| Pulse | DEN7A/ DEN7B/DEN10B: | 1 Hz — 20 kHz | 50Hz | Similar |
| repetition | 0.5Hz-500Hz | |||
| rate | CHEESEII-7A/7B/10B: 0.05Hz-20 | |||
| KHz | ||||
| GBOX-15A/ 15B/ 20B: 0.05Hz-20 | ||||
| KHz | ||||
| GBOX-15AB: 1Hz-20 KHz | ||||
| Aiming | 650±10 nm, 5mw (max) | 650±20 nm, Pmax<5 mW | 5mW laser diode, 650nm, Class 1 | Substantial |
| Beam | Equivalence | |||
| Delivery | Fiber optic cable (200µm, 400µm, | Fiber optic cable (200µm, 300µm, | Fiber optic cable (400µm) and fiber | Substantial |
| system | 600µm and 800µm), handpiece and | 400 µm), handpiece and Single-use | tips | Equivalence |
| fiber tips | fiber tips | |||
| Operation | Color touch screen graphical user | Color touch screen graphical user | Electroluminescent glass display with | Substantial |
| Item | Proposed device | Predicate device(K210367) | Reference device(K192617) | Discussion |
| Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | ||
| interface | interface | interface | capacitive touch interface. Capacitive touch is a hard plastic. | Equivalence |
| ActivationMeans | Foot Switch, with electronic access key | Handpiece finger switch.Wireless foot switch. | Wireless Foot Switch, with electronic access key | SubstantialEquivalence |
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VII Summary of Non-clinical tests:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Medical Diode Laser System.
- -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).
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
VIII Clinical Testing
It is not applicable.
IX Conclusion
The Medical Diode Laser System is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 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.