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 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

The Gemini 2 810+980 Soft Tissue Laser is an 810+980nm soft tissue laser intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue and for pain relief using Photobiomodulation. The Gemini 2 810+980 Soft Tissue Laser operates at a wavelength of 810±10nm or at 980±10nm or a combination of both 810+980nm, with a maximum average power output of 2.0 watts ± 20%. The system also contains a 2mW, 650nm laser diode coupled to the same fiber optic cable to produce a red aiming light for the infrared laser beams.

The laser energy is generated in an internal laser module and is then channeled through a flexible optical fiber that is permanently connected to a hand piece. Single-use disposable tips, or Photobiomodulation (PBM) adapters, become the laser aperture of the device when they are optically coupled to the fiber in the hand piece. The disposable tips and Photobiomodulation tips are interchangeable and provide a method of delivering laser energy to the target area.

The laser unit is comprised of a molded plastic housing that contains: the laser module, main PCB with integrated MCU and laser controller, an electroluminescent display connected to an interface PCB, a touch sensitive graphic user interface with status indicators, and a rechargeable lithium-ion battery.

The handpiece used by the practitioner consists of a cylindrical body of anodized aluminum which encloses the optics that transmit the laser energy to the disposable fiber tip or PBM adapters. The red aiming light is emitted directly from the aperture of the laser attached to the hand piece. Additionally, the handpiece illuminates the target work area with bright white LED lights during procedures through the translucent disposable tips.

The wireless footswitch provides hands-free laser activation. The switch utilized high band Bluetooth technology to wirelessly control the initiation and termination of laser power from the laser aperture. Haptic feedback is also incorporated into the foot pedal to provide a vibration upon laser activation which can be adjusted from low to medium, or high,

The single-use disposable fiber tip includes a translucent plastic tip body, stainless steel tube and a 400-micron polished optical fiber. The Gemini 2 810 + 980 Soft Tissue Laser was designed to utilize the same disposable tip as the Gemini 810+980 Soft Tissue Laser, previously cleared by FDA (K192617).

The PBM adapters are accessory attachments for the Gemini 2 810 + 980 Soft Tissue Laser which expand the diameter of the laser beams spot size to 25mm, 3mm or 7mm. The lager diameter laser beam is used for Photobiomodulation indications such as pain management. The PBM adapters are designed to be held in a fixed location for the duration of the treatment. The 25mm adapter is only intended for extraoral use directly on intact skin and is designed at a diameter for larger work areas. Single-use disposable spacers are intended to be used with the 25mm adapter to limit the risk of cross contamination between patients. Due to the extraoral use, and disposable spacers, the 25mm PBM adapter is not to be steam sterilized. The 3mm and 7mm PBM tips are intended to be used intraorally and are designed at an I angle for reaching the back of the mouth. Steam sterilization and cleaning are required for both the 3mm and 7mm PBM adapters before each use. Non-clinical testing was conducted on the 3mm and 7mm adapters to test that the adapters increased the intra oral tissue temperature to the FDA quidelines for the ILY product code. The results showed that even in the intraoral environment, the efficacy of the adapters was met and showed substantial equivalence to the previously cleared device. In addition, non-clinical testing was also conducted with the use of an FDA cleared barrier sleeve over the 3mm and 7mm Intra Oral adapters. The results show that the use of the sleeve did not affect the efficacy of the product.

The laser unit is controlled by a Main Control Unit (MCU) processor that is integrated into the main PCB. The PCB contains the software and hardware which requlates voltages and current and controls all the other functions and safety features. The PCB may be powered by either lithium-ion battery pack, or the included AC power supply. The PCB was designed to allow the power supply to provide power to the unit while simultaneously charging the battery pack.

The Gemini 2 810+980 Soft Tissue Laser utilizes non-volatile, preprogrammed firmware that cannot be modified by the user. Additionally, custom presets and individual user settings are stored in memory to be adjusted by users at any time. During the development process, regulations are recognized and applies to meet requirements, potential hazards are evaluated and mitigated for the safety of the patient and/or the operator. The Gemini 2 810 + 980 Soft Tissue Laser has software features that allows for access to training videos, user manuals and software updates.

AI/ML Overview

The provided document is a 510(k) summary for the Azena Medical, LLC Gemini 2 810+980 Soft Tissue Laser. It does not describe a study involving human readers, AI, or the establishment of ground truth by expert consensus for diagnostic purposes.

Instead, this document details the device's technical specifications, its intended use (dental soft tissue procedures and pain therapy via topical heating), and demonstrates its substantial equivalence to previously cleared predicate devices (Gemini 810+980 Diode Laser and Epic Pro Diode Laser System).

The acceptance criteria and performance data discussed are related to:

Compliance with international and national standards for medical electrical equipment, laser products, sterilization, and biocompatibility.
Bench testing to verify performance characteristics like power output and tissue temperature elevation.
Software validation according to IEC 62304.

Therefore, I cannot provide the information requested in terms of AI performance, human reader improvement, expert ground truth establishment, or data provenance relevant to an AI-assisted diagnostic study. The document explicitly states: "No clinical data was submitted for this Traditional 510(k)." This means there were no human subject studies to evaluate the device's performance in a clinical setting in the way you might find for an AI diagnostic device.

However, I can extract the acceptance criteria and demonstrated performance based on the type of evaluation conducted for this specific device, which is a medical laser for surgical and therapeutic use, not a diagnostic AI.

Here's a breakdown of the relevant information from the provided text, framed to address your questions where applicable, and noting where the information is not applicable (N/A) to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this laser device, the "acceptance criteria" are compliance with recognized safety and performance standards, and demonstrating equivalent performance to predicate devices through bench testing.

Acceptance Criteria (Demonstrated Compliance/Equivalence)	Reported Device Performance
Safety and Performance Standards Compliance:
21 CFR 1040.10 & 1040.11 (Laser Product Performance Standards)	Compliant (except for deviations pursuant to laser notice 50 dated June 24, 2007)
IEC 60601-2-22 Edition 4 2019 (Medical electrical equipment - Part 2: Lasers)	Compliant
IEC 60825-1 Edition 3 2014 (Safety of laser products - Part 1: Classification)	Compliant
AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 (General requirements for basic safety)	Compliant
IEC 60601-1-2 Edition 4.0 2014-02 (Electromagnetic compatibility)	Compliant
AAMI/ANSI ST81:2004/(R)2016 (Sterilization, Packaging)	Compliant
AAMI/ANSI ST79:2017 (Steam Sterilization)	Compliant
AAMI/ANSI/ISO 17665-1:2006/(R)2013 (Sterilization of health care products - Moist heat)	Compliant; 10^-6 SAL demonstrated for 135°C 10-minute gravity steam sterilization of Anodized Aluminum Hand Piece Shell and Intra oral PBM adapters.
AAMI/ANSI/ISO 17665-2:2009-01-15 (Sterilization of health care products - Moist heat)	Compliant
AAMI/ANSI/ISO 10993-5:2009/(R)2014 (Biological evaluation of medical devices - Cytotoxicity)	Compliant
IEC 62304 (Medical device software - Software lifecycle processes)	Compliant (software documentation of moderate level of concern)
Functional Equivalence:
Max Peak Power Output equivalence to Epic Pro Diode Laser System	Testing concluded that the Gemini 2 performs equivalently, with a peak power of up to 150W.
Average Power Output equivalence to Gemini 810+980 Soft Tissue Laser (predicate)	Found to be substantially equivalent to the original Gemini in terms of average power output of 2.0W.
Tissue Temperature Elevation for PBM adapters (ILY product code)	Non-clinical testing was conducted on the 3mm and 7mm intraoral PBM adapters to show they increased intraoral tissue temperature to FDA guidelines for the ILY product code, demonstrating efficacy and substantial equivalence to the previously cleared device. Testing also showed no effect on efficacy with an FDA cleared barrier sleeve. Extraoral 25mm PBM adapter also tested for mechanism of action.
Basic operation and features specified in 21 CFR 1040.10	Bench testing confirmed the device meets these features and functions.
Cleaning Validation	Re-processing of Anodized Aluminum Surgical Hand Piece with Fiber Connector validated according to FDA Reprocessing Guidance.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: N/A for human subject data. The "test set" here refers to physical devices, components, and software evaluated through bench testing and compliance verification. The document doesn't specify the number of units tested, which is common for this type of submission.
Data Provenance: N/A. The data is generated from laboratory bench tests, sterilization validations, electrical safety, EMC, and software testing, performed by the manufacturer or contracted labs. It's not clinical data in terms of patient populations or geographical origin. This was a non-clinical submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This device submission does not involve diagnostic ground truth established by medical experts (e.g., radiologists, pathologists). The "ground truth" for this laser device is based on objective measurements from engineering and performance testing against established standards and predicate device specifications.

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

N/A. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. The data presented here is from objective engineering and performance tests, not clinical adjudication.

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. An MRMC comparative effectiveness study was not done. This device is a surgical/therapeutic laser, not an AI-powered diagnostic tool for human readers. This type of study is not relevant to its clearance.

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

N/A. This device is a physical laser system, not an algorithm. While it contains software, its "performance" is measured by its physical output (laser power, wavelength, impact on tissue temperature), not by its ability to perform a diagnostic task independently.

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

The "ground truth" for this device, in terms of its regulatory submission, is based on:
- Objective Engineering Specifications: Agreed-upon laser parameters (wavelength, power output, beam diameter).
- Recognized National and International Standards: Established safety, performance, and sterilization criteria (e.g., IEC, ISO, AAMI/ANSI).
- Predicate Device Specifications: The performance characteristics of legally marketed devices to which substantial equivalence is claimed.
- In-vitro Bench Testing Results: Measurements of physical properties and effects (e.g., tissue heating).

8. The sample size for the training set:

N/A. This submission does not involve a "training set" in the context of machine learning model development.

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

N/A. As there is no training set mentioned in the context of an AI/ML model, this question is not applicable.

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 18, 2021

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

Re: K210350

Trade/Device Name: Gemini 2 810+980 Soft Tissue 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: NVK, GEX, ILY Dated: October 19, 2021 Received: October 21, 2021

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210350

Device Name Gemini 2 810 +980 Soft Tissue 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

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X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K210350

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 1. summary prepared:

Submitter:	Azena Medical, LLC3021 Citrus Cir Ste 180,Walnut Creek, CA 94598
Contact Person:	Lindsay TiltonRegulatory & Quality Affairs ManagerPhone: 800-466-5273Email: Itilton@azenamedical.com

Date of Preparation: November 17, 2021
Name of device, including the trade name and classification name: 2.

Trade Name:	Gemini 2 810+980 Soft Tissue Laser
Common Name(s):	Laser, dental soft tissue,Powered laser surgical instrument, Infrared lamp
Classification Name(s):	Laser surgical instrument for use in general andplastic surgery and in dermatology
Regulation Number:	21 CFR 878.4810

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Device Class: Class II

Primary Product Code:	NVK
Additional Product Code:	GEX,ILY

Classification Panel:	General dental and Plastic Surgery & OthersPhysical 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:	Gemini 810+980 Diode laser
510(k):	K192617
Date Cleared:	February 20, 2020

Reference Predicate Device:

Company:	Biolase Technology, Inc.
Device:	Epic Pro Diode Laser System
510(k):	K163128
Date Cleared:	January 11, 2017

1. 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):
  The Gemini 2 810+980 Soft Tissue Laser is an 810+980nm soft tissue laser intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue and for pain relief using Photobiomodulation. The Gemini 2 810+980 Soft Tissue Laser operates at a wavelength of 810±10nm or at 980±10nm or a combination of both 810+980nm, with a maximum average power output of 2.0 watts ± 20%. The system also contains a 2mW, 650nm laser diode coupled to the same fiber optic cable to produce a red aiming light for the infrared laser beams.

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Photobiomodulation tips are interchangeable and provide a method of delivering laser energy to the target area.

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regulations are recognized and applies to meet requirements, potential hazards are evaluated and mitigated for the safety of the patient and/or the operator. The Gemini 2 810 + 980 Soft Tissue Laser has software features that allows for access to training videos, user manuals and software updates.

5. INDICATIONS FOR USE:

Dental Soft Tissue Indications

Incision, excision, vaporization, ablation and coagulation 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 ●

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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 strains, and minor muscular back pain, the temporary increase in local blood circulation; the temporary relaxation of muscle.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

	Gemini 2 810 + 980 SoftTissue LaserSubject Device	Gemini 810 + 980 DiodeLaserPrimary Predicate	Epic Pro Diode LaserSystemReference predicatedevice
LaserClassification	IV (4)	IV (4)	IV (4)
	Gemini 2 810 + 980 SoftTissue LaserSubject Device	Gemini 810 + 980 DiodeLaserPrimary Predicate	Epic Pro Diode LaserSystemReference predicatedevice
Type of Laser	Diode Laser	Diode Laser	Diode Laser
Laser Medium	GaAIAs	GaAIAs	InGaAsP
Product Code(s)	NVK; GEX; ILY	GEX; ILY	GEX
Wavelength	810 ± 10nm; or980 ± 10nm; or810nm and 980nm ±10nm	810 ± 10nm; or980 ± 10nm; or810nm and 980nm ±10nm	980nm ± 20nm
Average OutputPower	Adjustable 0.1 - 2 Watts	Adjustable 0.1 - 2 Watts	Adjustable 0.1 – 25.0 Watts
Max Peak OutputPower	150 Watts	20 Watts	150 Watts
Increments ofPower Available	0.1 Watts	0.1 Watts	0.2-1 Watts
Operating Voltage	100-240 VAC	100-240 VAC	100V - 240V at1.2A/0.5A
Current Frequency	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	None
Delivery System	Quartz glass fiber & tip	Quartz glass fiber & tip	Fiber optic cable,handpiece anddisposable fiber tips
Fiber/Tip Diameter	400 µm flexible fiber opticcable	400 µm flexible fiber opticcable	300 - 400 µm
Spot Size at Target	400 µm diameter; 25mmPBM Adapter, 7mm PBMAdapter and 3mm PBMAdapter	400 µm diameter; 25mmPBM Adapter	300 - 400 µm
Fiber Aiming Beam	2mW laser diode,650nm, Class 1	5mW laser diode,650nm, Class 1	5mW laser diode, 650nm
Activation Means	Wireless Foot Switch,with electronic accesskey	Wireless Foot Switch,with electronic accesskey	Wireless Foot Switch
Materials	Medical grade plastics,steel, stainless steel,aluminum, brass, glass,and electronic parts and	Medical grade plastics,steel, stainless steel,aluminum, brass, glass,and electronic parts and	Medical grade plastics,steel, stainless steel,aluminum, brass, and
	Gemini 2 810 + 980 SoftTissue LaserSubject Device	Gemini 810 + 980 DiodeLaserPrimary Predicate	Epic Pro Diode LaserSystemReference predicatedevice
	components	components	electronic parts andcomponents
UserInterface	Electroluminescentglassdisplay with capacitivetouchinterface. Capacitivetouchis a hard plastic.	Electroluminescentglassdisplay with capacitivetouchinterface. Capacitivetouchis sticker overlay.	Color front graphicaluserinterface with deadfrontcapacitive touchbuttons.
Pre-SetProcedures	Three differentcategories –Surgical, Non-SurgicalandPain Relief	Four differentcategories -General Dentistry,Orthodontics, HygieneandPain Relief	Multiple pre-setprocedures
ProductUpdateConnectivity	Software updateperformedvia app over Wi-Ficonnection (wireless)	Software updateperformedvia USB plugged intocomputer (hardwire)	Software updateperformedvia USB plugged intocomputer (hardwire)
Haptic Feedback inFoot Pedal	Yes	n/a	n/a

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The Gemini 2 810 + 980 Soft Tissue Laser has the equivalent indications for use and similar technological characteristics as that of the Predicate Device. The minor differences that exist between the Gemini 2 810 + 980 Soft Tissue Laser and the Predicate Device 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. Average power output is a dominant established factor when comparing laser devices and studies. These minor technological differences therefore raise no new questions of safety or effectiveness.

7. Performance Data:

The Gemini 2 810 + 980 Soft Tissue 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 4 2019
IEC 60825-1Edition 3 2014 .
AAMI/ANSI ES60601-1:2005/ (R) 2012 and A1:2012 ●

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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

Cleaning validation was conducted according to FDA Reprocessing Guidance. 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 ten-minute gravity steam sterilization cycle at 135°C for the Anodized Aluminum Hand Piece Shell. Steam sterilization validation was conducted using a half-cycle method per ISO 17665-1 and -2 and demonstrated a SAL of 10^-6. The gravity cycle of 135°C at 10 minutes is validated for the Anodized Aluminum Hand Piece Shell.

Sterilization validation was conducted to validate a ten-minute gravity steam sterilization cycle at 135°C for the Intra oral PBM adapters. Steam sterilization was conducted using a half-cycle method per ISO 17665-1 and -2 and demonstrated a SAL of 10^-6. The gravity cycle of 135°C at 10 minutes is validated for the Intra oral PBM adapters.

Electrical Safetv and EMC Testing

Testing to verify the conformity of the Gemini 2 810 + 980 Soft Tissue 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 2 810+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 2 810+980 Diode Laser to IEC 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements).

Testing to verify the performance of Gemini 2 810+980 Diode Laser according to IEC 60601-2-22: (Medical electrical equipment Part 2: Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).

Software

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Validation of the device's software in conformity with IEC 62304 (Medical device software - Software lifecycle processes) and software documentation of moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices

Non-Clinical

Bench testing was also conducted on the Gemini 2 810 + 980 Soft Tissue Laser and found that Gemini 2 810 + 980 Soft Tissue Laser meets the features and functions as identified in 21 CFR 1040.10.

Comparative bench testing was conducted on Azena's Gemini 2 810+980 Diode Laser against Biolase's Epic Pro for maximum peak power output and against Azena's Gemini 810+980 Diode Laser for average power output. It was found that the Gemini 2 810+980 Diode Laser is substantially equivalent to the original Gemini in terms of average power output of 2.0W. Testing against the Epic Pro concluded that the Gemini 2 performs equivalently, with a peak power of up to 150W.

Tissue temperature testing was conducted on all the Gemini 2 PBM adapters to show the mechanisms of action for ILY product code, lamp, infrared, therapeutic heating meet performance expectations.

The performance data, alonq with conformity to the recognized national and international standards cited above, demonstrates that the Gemini 2 810 + 980 Soft Tissue Laser performs as well as its predicate devices.

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

8. Conclusions:

The Gemini 2 810 + 980 Soft Tissue Laser has the equivalent indications for use and characteristics as that of the Predicate Device. The minor technological differences that exist between the Gemini 2 810 + 980 Soft Tissue 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 2 810 + 980 Soft Tissue Laser is as safe and as effective as its Predicate Device. Comparative bench testing shows that the Gemini 2 810 + 980 Soft Tissue Laser is substantially equivalent to the Gemini 810 + 980 Soft Tissue Laser and Epic Pro.

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.