Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

· Excisional and incisional biopsies
· Exposure of unerupted teeth
Fibroma removal
· Frenectomy
· Frenotomy
· Gingival troughing for crown 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 root canal therapy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Treatment of aphthous ulcers.
· Vestibuloplasty
· Tissue retraction for impression
· Lesion (tumor) removal.

Laser Periodontal Procedures.

· Laser soft tissue curettage.
· Laser removal of diseased, Inflamed and necrosed soft tissue within the periodontal pocket.

· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

· 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 mobility)

· Reduction of bacterial level (decontamination) and inflammation

Pain therapy

· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain, the temporary increase in local blood circulation; the temporary relaxation of muscle.

Device Description

Gemini is an 810nm + 980nm soft tissue laser is intended for the incision, ablation, vaporization, hemostasis and treatment of oral soft tissue and for pain relief using photobiomodulation. The Gemini laser operates at a wavelength of 810nm +/- 10nm or at 980 +/- 10nm or a combination of both 810nm + 980nm wavelengths, with a maximum average power of 2 watts +/- 20% and maximum peak pulse power of 20 watts +/- 20% when in dual wavelength mode. The dual wavelength diode laser radiation is delivered through a flexible optical fiber and the Photobiomodulation (PBM) Adapter. Infrared laser energy is emitted from the fiber tips and the PBM Adapter when the wireless footswitch is depressed. The laser diodes are directly coupled to the flexible fiber optic able that connects the laser unit to the surgical hand piece and to the disposable fiber tip and PBM Adapter that emits the energy to the target area. The laser diodes can simultaneously emit energy when Gemini is set to dual wavelength mode.

The Gemini unit comprises of six main assemblies: a Laser unit, a flexible fiber optic delivery svstem tethered to an anodized aluminum hand piece, disposable single-use fiber tips. PBM Adapter with spacers, a wireless footswitch, and an auxiliary power supply. The system also contains a 5mW 650nm laser diode coupled to the same fiber optic cable to produce the red aiming light. The laser system is contained within a compact lightweight impact resistant molded plastic housing that contains a laser diode assembly, a laser power controller PCB, an Electroluminescent Display connected to an interface PCB, a touch sensitive selection panel with status lights, and a rechargeable Lithium Battery. The hand piece used by the practitioner consists of an anodized aluminum cylindrical body which encloses the optics used to transfer the laser energy to the single-use fiber tips and the PBM Adapter. The LED illumination system for lighting the work area will be off for PBM Adapter.

The laser's visible light is designed to aid the clinician in aiming the tip of the delivery fiber into the target tissue. Additionally, a bright white light from the LEDS in the hand piece illuminates target work area during procedures through the translucent disposable laser tips.

The PBM Adapter is an accessory attachment to the Gemini laser system to increase the spot size of the laser beam, allowing the Gemini Laser to provide near-infrared laser energy to a tissue surface for the purpose of photobiomodulation. Affected muscles and/or joints must be exposed to an adequate level of laser energy over a period of time to provide effective results. The spot size of the PBM Adapter is 25 mm. The PBM Adapter operates at 810nm ± 10nm wavelength with a maximum average power of 1 watt ± 20%.

A PBM spacer is attached to the PBM Adapter. The spacer is a single-use disposable piece designed to ensure proper working distance to target tissues and limit the risk of cross contamination between patients. The PBM Adapter is designed to only work with the Gemini Laser System.

Gemini 810 + 980 Diode Laser utilizes non-volatile, preprogrammed firmware that cannot be modified by the user. During the development process, requirements are met, hazards are evaluated and mitiqated for the safety of the patient and /or the operator and the firmware. It does not capture any data related to patients. The Gemini software focuses on the functional and technical design for the Gemini laser. This includes the graphical user interface (GUI), the control of the laser drivers, sound, tip illumination and aiming light.

AI/ML Overview

The provided text is a 510(k) summary for the Gemini 810+980 Diode Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and non-clinical performance data.

Crucially, this document does not describe a study involving a "test set" with "ground truth established by experts" or a "multi-reader multi-case (MRMC) comparative effectiveness study" for an AI or imaging device. It is for a laser surgical instrument and pain therapy device.

Therefore, many of the requested items related to AI/imaging device validation (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set and training set) are not applicable to this submission.

The document states: "No clinical data was submitted for this Traditional 510(k)." This further confirms that there were no human subject studies to evaluate the device's performance in a clinical setting in the way an AI/imaging device would be evaluated.

However, I can extract information related to the acceptance criteria and the studies that were performed to support the substantial equivalence claim for this specific type of device.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance:

Since this is a laser device and not an AI/imaging diagnostic tool, the "acceptance criteria" are compliance with various national and international standards, and "reported device performance" refers to the results of bench testing confirming these compliances and functional equivalence to predicate devices.

Acceptance Criteria (Compliance with Standards/Functional Equivalence)	Reported Device Performance (Study Results)
Laser Safety & Performance Standards:	- 21 CFR 1040.10 & 1040.11: Found in compliance (except for deviations pursuant to laser notice 50 dated June 24, 2007).
- IEC 60601-2-22 Edition 3.1 2012-10	- Conformed to IEC 60601-2-22 (Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).
- IEC 60825-1 Edition 2.0 2007-03	- Conformed to IEC 60825-1 (Safety of laser products – Part 1: Equipment classification and requirements).
Electrical Safety & EMC Standards:	- AAMI/ANSI ES60601-1:2005/ (R) 2012 and A1:2012: Conformed to IEC 60601-1 (General requirements for basic safety and essential performance).
- IEC 60601-1-2 Edition 4.0 2014-02	- Conformed to IEC 60601-1 -2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic compatibility).
Cleaning & Sterilization Standards:	- AAMI/ANSI ST81:2004/(R)2016
- AAMI/ANSI ST79:2017	- Cleaning Validation (Anodized Aluminum Surgical Hand Piece with Fiber Connector): Achieved 78.5% protein recovery and 77.6% hemoglobin recovery. Cleaned devices contained < 5.4 uq/cm² protein and < 1.6 µq/cm² hemoglobin. Cleaning procedure validated.
- AAMI/ANSI/ISO 17665-1:2006/(R)2013	- Sterilization Validation (Anodized Aluminum Hand Piece Shell): Fifteen-minute gravity steam sterilization cycle at 135°C validated. No growth of biological indicators; verified half cycle indicates 12 log reduction capability and 10^-6 sterility assurance level for a worst-case population. 15-minute gravity cycle at 135°C validated.
- AAMI/ANSI/ISO 17665-2:2009-01-15
Biocompatibility Standards:	- AAMI/ANSI/ISO 10993-5:2009/(R)2014 (The document lists this standard but does not explicitly state the results of such testing, only that the device was tested in accordance and found in compliance with the listed standards.)
Software Validation:	- Conformed to IEC 62304 (Medical device software - Software lifecycle processes).
Functional Equivalence for Pain Management Indication:	- Comparative bench testing with Biolase Epic 10 (pain therapy handpiece): Resulted in similar power density and spot size. Concluded Gemini with PBM Adapter is substantially equivalent to Epic 10 for pain management laser energy output.
Therapeutic Heating Mechanism (Pain Therapy):	- Skin temperature testing: Demonstrated that Gemini 810+980 Diode Laser with PBM Adapter increases topical heat at the tissues level to 40 degrees Celsius and can maintain this temperature for a minimum of 10 minutes during treatment, which aligns with the mechanism of action for ILY product code (therapeutic heating to 40-45°C for ≥10 minutes).
General Functional Compliance (21 CFR 1040.10):	- Bench testing: Found that Gemini meets the features and functions as identified in 21 CFR 1040.10.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable in the context of an "AI/imaging test set": As stated, no clinical data was submitted. The testing involved bench testing of the device and its components, not a "test set" of patient data for diagnostic evaluation. Sample sizes for bench tests (e.g., number of units tested for electrical safety, cleaning/sterilization) are standard engineering and quality assurance practices and are not detailed in this summary.

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: No "ground truth" was established by medical experts for a test set of patient data, as this device is a laser surgical and pain therapy instrument, not an AI diagnostic tool.

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

Not Applicable: No clinical test set requiring adjudication of findings was used.

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

Not Applicable: This is not an AI-assisted diagnostic device. No MRMC study was performed.

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

Not Applicable: This is a physical medical device, not an algorithm. Bench testing confirmed its standalone performance against engineering specifications and comparison with predicate devices.

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

Not Applicable in the typical AI/imaging sense. For this device, "ground truth" for its performance is derived from:
- Compliance with recognized industry standards: The standards themselves define acceptable parameters and measurement methodologies.
- Bench test results: Physical measurements of power output, wavelength, temperature achieved, cleaning efficacy, sterilization efficacy, etc., verified by instruments and documented procedures.
- Comparison to predicate device specifications/performance: Demonstrating that its physical and energy output characteristics are equivalent or superior to already cleared devices.

8. The sample size for the training set

Not Applicable: This device does not use a "training set" in the context of machine learning.

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

Not Applicable: No training set was used.

Summary

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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. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Azena Medical, LLC Lindsay Tilton Regulatory & Quality Affairs Manager 3021 Citrus Circle Ste 180 Walnut Creek, California 94598

Re: K192617

Trade/Device Name: Gemini 810+980 Diode Laser 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: GEX, ILY Dated: January 2, 2020 Received: January 21, 2020

Dear Lindsay Tilton:

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

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

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about 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).

Sincerely,

Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K192617

Device Name Gemini 810 +980 Diode Laser

Indications for Use (Describe)

Dental Soft Tissue Indications

Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

· Excisional and incisional biopsies
· Exposure of unerupted teeth
Fibroma removal
· Frenectomy
· Frenotomy
· Gingival troughing for crown 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 root canal therapy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Treatment of aphthous ulcers.
· Vestibuloplasty
· Tissue retraction for impression
· Lesion (tumor) removal.

Laser Periodontal Procedures.

· Laser soft tissue curettage.
· Laser removal of diseased, Inflamed and necrosed soft tissue within the periodontal pocket.

· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

· Reduction of bacterial level (decontamination) and inflammation

Pain therapy

· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and

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stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain, the temporary increase in local blood circulation; the temporary relaxation of muscle.

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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Section 5

510(k) Summary

510(k) Summary of Safety and Effectiveness

Traditional 510(k) Premarket Notification

Submitter:

Azena Medical, LLC 3021 Citrus Cir Ste 180 Walnut Creek, CA 94598

Phone: (800) 466 - 5273

Regulatory Authority:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92.

Submitter's name, address, telephone number, contact person, and date summary 1. prepared:

Submitter:	Azena Medical, LLC3021 Citrus Cir Ste 180Walnut Creek, CA 94598
------------	-------------------------------------------------------------------------

Contact Person:	Lindsay TiltonRegulatory & Quality Affairs ManagerPhone: 800-466-5273Email: ltilton@azenamedical.com
-----------------	------------------------------------------------------------------------------------------------------------------

Date of Preparation: February 12, 2020
1. Name of device, including the trade name and classification name:

Trade Name:	Gemini 810 + 980 Diode Laser
Common Name(s):	Powered laser surgical instrument, Infrared lamp
Classification Name(s):	Laser surgical instrument for use in general and plastic surgery andin dermatology; and infrared lamp
Regulation Number:	21 CFR 878.4810
Device Class:	Class II for all requested indications
Product Code:	GEX, ILY

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Classification Panel:	General and Plastic Surgery & Others
	Physical Medicine Therapeutic Devices

1. ldentification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Primary Predicate Device:

Company:	Azena Medical, LLC
Device:	Elumi 810+980 Soft Tissue Laser
510(k):	K152032
Date Cleared:	September 16, 2015

Reference Predicate Device:

Company:	Biolase Technology, Inc.
Device:	Epic 10
510(k):	K121286
Date Cleared:	September 28, 2012

4. A description of the device that is the subject of the 510(k), including an explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

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the laser energy to the single-use fiber tips and the PBM Adapter. The LED illumination system for lighting the work area will be off for PBM Adapter.

5. INDICATIONS FOR USE:

The indications for use are identical to those of the previously cleared Predicate Device, ELUMI 810+980 Soft Tissue Laser and similar to the Epic 10 Laser. The only difference with the ELUMI 810+980 Soft Tissue Laser is that device is not cleared for the indication of Pain Management.

Dental Soft Tissue Indications

Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marqinal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

. Excisional and incisional biopsies
. Exposure of unerupted teeth
. Fibroma removal
. Frenectomy
Frenotomy ●
. Gingival troughing for crown impressions

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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 root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ●
Treatment of aphthous ulcers.
Vestibuloplasty ●
Tissue retraction for impression ●
Lesion (tumor) removal. .

Laser Periodontal Procedures.

Laser soft tissue curettage. ●
Laser removal of diseased, Inflamed and necrosed soft tissue within the . periodontal pocket.
. Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.
. 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 mobility)

{8}------------------------------------------------

Reduction of bacterial level (decontamination) and inflammation ●
Pain therapy
Topical heating for the purpose of elevating tissue temperature for a 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE:

	Gemini 810 + 980Diode Laser	Elumi Soft TissueLaserPrimary Predicate	Epic 10Reference predicatedevice
LaserClassification	IV (4)	IV (4)	IV (4)
Type of Laser	Diode Laser	Diode Laser	Diode Laser
Laser Medium	GaAlAs	GaAlAs	InGaAsP
Product Code(s)	GEX; ILY	GEX	GEX; ILY
Wavelength	810 ± 10nm; or980 ± 10nm; or810nm and 980nm ±10nm	810 ± 10nm; or980 ± 10nm; or810nm and 980nm ±10nm	940 ± 10 nm
Average OutputPower	Adjustable 0.1 - 2Watts	Adjustable 0.1 - 2Watts	Adjustable 0.1 – 10.0Watts
Max Peak OutputPower	20 Watts	20 Watts	10 watts
Increments ofPower Available	0.1 Watts	0.1 Watts	0.1 Watts
Operating Voltage	100-240 VAC	100-240 VAC	100-240 VAC
CurrentFrequency	50-60 HZ	50-60 HZ	50-60 Hz
Operation Mode	Pulsed	Pulsed	Pulsed, Continuous
Pulse Type	Gated	Gated	Gated
Battery	Lithium IonRechargeable	Lithium IonRechargeable	Lithium IonRechargeable
Delivery System	Quartz glass fiber & tip	Quartz glass fiber & tip	Quartz glass fiber & tip

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Fiber/TipDiameter	400 µm flexible fiberoptic cable	400 µm flexible fiberoptic cable	200 µm, 300 µm, 400µm flexible fiber OpticCable
Spot Size atTarget	400 µm diameter;25mm PBM Adapter	400 µm diameter	200 µm, 300 µm, 400µm diameter;adjustable 15-30 mmPain managementhandpiece
Fiber AimingBeam	5mW laser diode,650nm, Class 1	5mW laser diode,650nm, Class 1	Laser Diode max.1mW, 635 ± 10 nm,class 1
Activation Means	Wireless Foot Switch,with electronic accesskey	Wireless Foot Switch,with electronic accesskey	Wireless Foot Switch,with electronic accesskey

The Gemini 810 + 980 Diode Laser has the equivalent indications for use and technological characteristics as that of the Predicate Device with the exception of pain management, which is indicated in the reference predicate device indications for use. The difference that exist between the Gemini 810 + 980 Diode Laser and the Predicate Devices do not alter the fundamental scientific technology of the device, and most importantly have no effect on the ability of either laser system to output laser energy at safe and effective levels of average power.

7. Performance Data:

The Gemini 810 + 980 Diode Laser was tested in accordance, and found to be in compliance, with the following national and international standards:

21 CFR 1040.10 & 1040.11 except for deviations pursuant to laser notice 50 dated June 24. 2007
IEC 60601-2-22 Edition 3.1 2012-10 ●
IEC 60825-1Edition 2.0 2007-03 ●
AAMI/ANSI ES60601-1:2005/ (R) 2012 and A1:2012 ●
IEC 60601-1-2 Edition 4.0 2014-02
AAMI/ANSI ST81:2004/(R)2016 ●
AAMI/ANSI ST79:2017
. AAMI/ANSI/ISO 17665-1:2006/( R)2013
AAMI/ANSI/ISO 17665-2:2009-01-15
AAMI/ANSI/ISO 10993-5:2009/( R)2014 .

Cleaning and Sterilization

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Cleaning validation was conducted according to FDA Reprocessing Guidance. The recovery method for the Anodized Aluminum Surgical Hand Piece with Fiber Connector achieved 78.5% and 77.6% recoveries for protein and hemoglobin respectively. All cleaned devices for the Anodized Aluminum Surgical Hand Piece with Fiber Connector were found to contain < 5.4 uq/cm² and < 1.6 µq/cm² for protein and hemoglobin respectively. The cleaning procedure is validated for the reprocessing of the Anodized Aluminum Surgical Hand Piece with Fiber Connector.

Sterilization validation was conducted to validate a fifteen -minute gravity steam sterilization cycle at 135°C for the Anodized Aluminum Hand Piece Shell. There was no growth of the biological indicators that had been exposed to steam with the test article. The verified half cycle indicates that a full gravity cycle of not less than 15 minutes at 135°C is capable of a 12 log reduction and will provide a 10-6 sterility assurance level of a worst case population. The gravity cycle of 135°C at 15 minutes is validated for the Anodized Aluminum Hand Piece Shell.

Electrical Safety and EMC Testing

Testing to verify the conformity of the Gemini 810+980 Diode Laser, with the requirements of IEC 60601-1: (Medical electrical equipment Part 1: General requirements for basic safety and essential performance).

Testing to verify the conformity of the Gemini 810+980 Diode Laser 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).

Testing to verify the conformity of the Gemini 810+980 Diode Laser to IEC 60825-1 (Safety of laser products – Part 1: Equipment classification and requirements).

Testing to verify the performance of Gemini 810+980 Diode Laser 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

Validation of the device's software in conformity with IEC 62304 (Medical device software -Software lifecycle processes).

Non-Clinical

Bench testing was also conducted on the Gemini 810+980 Diode Laser and found that Gemini meets the features and functions as identified in 21 CFR 1040.10.

Comparative bench testing was conducted on Gemini 810+980 Diode Laser using the new PBM Adapter in comparison with Biolase Epic 10 with pain therapy handpiece to ensure equivalence in pain management laser energy output, therefore ensuring new indication for use equivalence. The testing resulted in similar power density and spot size. It was found that the Gemini with PBM Adapter is substantially equivalent to Epic 10 with pain therapy handpiece and laser energy output.

Skin temperature testing was also conducted. The mechanisms of action for ILY product code, lamp, infrared, therapeutic heating, is to raise the skin temperature to 40-45 degrees Celsius and maintain for a minimum of 10 minutes. It was determined that the Gemini 810+980 Diode

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Laser with PBM Adapter increases topical heat at the tissues level to 40 degrees Celsius and can maintain this temperature for a minimum of 10 minutes during treatment.

This performance data, along with conformity to the recognized national and international standards cited above, demonstrates that the Gemini 810 + 980 Diode Laser supports and performs as well as or better than its predicate devices.

No clinical data was submitted for this Traditional 510(k).

8. Conclusions:

The Gemini 810 + 980 Diode Laser has the equivalent indications for use and technological characteristics as that of the Predicate Device with the exception of the pain management indication. The minor differences in indications do not raise any new questions of safety or effectiveness. The original indications in Gemini were already cleared through a prior 510(k) (K152032). The minor technological differences that exist between the Gemini 810 + 980 Diode Laser and its predicate device do not alter the fundamental scientific technology of the device and raise no new questions of safety or effectiveness. Performance data demonstrates that the Gemini 810 + 980 Diode Laser is as safe and as effective as its Predicate Device. The addition of the pain management indication is equivalent to the reference device Biolase's Epic 10. Comparative bench testing shows that the Gemini laser is substantially equivalent when it comes to the pain management function against the Epic 10

Regulation Number and Section

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

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