(283 days)
No
The document describes a laser device with a microcontroller and preprogrammed firmware for controlling laser parameters and safety features. There is no mention of AI or ML algorithms for image processing, diagnosis, or treatment planning. The software features mentioned are for accessing training materials and updates, not for AI/ML functionalities.
Yes
The device is described as being used for various therapeutic purposes, including incision, excision, vaporization, ablation, hemostasis, and treatment of oral soft tissue, as well as pain relief using Photobiomodulation. The "Intended Use / Indications for Use" section lists numerous procedures that are therapeutic interventions, such as fibroma removal, frenectomy, gingivectomy, treatment of ulcers, and reduction of gingival hypertrophy, in addition to pain therapy.
No
The device is described as a soft tissue laser intended for various surgical procedures, pain therapy, and tissue modification in dental settings, not for diagnosis. Its functions are curative or procedural rather than diagnostic.
No
The device description clearly outlines significant hardware components including a laser module, optical fiber, handpiece, disposable tips, PBM adapters, a wireless footswitch, and a rechargeable battery. While it contains software (firmware), it is integral to the operation of the hardware and is not the sole component of the medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Gemini 2 810+980 Soft Tissue Laser is a therapeutic device that uses laser energy to directly treat oral soft tissues and provide pain relief. It performs procedures like incision, excision, vaporization, and ablation.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the patient. It directly interacts with the patient's tissues.
- Intended Use: The intended use clearly describes surgical and therapeutic procedures performed directly on the patient, not diagnostic testing of samples.
Therefore, the Gemini 2 810+980 Soft Tissue Laser falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
· 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.
Product codes
NVK, GEX, ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissues, periodontal pocket, oral mucosa, muscle, joint, back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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, 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 validation was conducted according to FDA Reprocessing Guidance for 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 and the Intra oral PBM adapters, demonstrating a SAL of 10^-6. Electrical safety and EMC testing were performed to verify conformity with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, and IEC 60601-2-22. Software validation was conducted in conformity with IEC 62304. Non-clinical bench testing was conducted on the Gemini 2 810 + 980 Soft Tissue Laser and found to meet the features and functions identified in 21 CFR 1040.10. Comparative bench testing against Azena's Gemini 810+980 Diode Laser showed substantial equivalence in terms of average power output of 2.0W. Testing against Biolase's Epic Pro concluded that the Gemini 2 performs equivalently, with a peak power of up to 150W. Tissue temperature testing was conducted on all Gemini 2 PBM adapters to demonstrate performance expectations for ILY product code, lamp, infrared, therapeutic heating. No clinical data was submitted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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
1
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
2
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.
· 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
3
· 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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, LLC
3021 Citrus Cir Ste 180,
Walnut Creek, CA 94598 |
|-----------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lindsay Tilton
Regulatory & Quality Affairs Manager
Phone: 800-466-5273
Email: 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 and |
| plastic surgery and in dermatology | |
| Regulation Number: | 21 CFR 878.4810 |
5
Device Class: Class II
| Primary Product Code: | NVK |
|---|---|
| Additional Product Code: | GEX,ILY |
| Classification Panel: | General dental and Plastic Surgery & Others
Physical Medicine Therapeutic Devices |
| ----------------------- | -------------------------------------------------------------------------------------- |
|---|
-
- ldentification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
Primary Predicate Device:
- ldentification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| 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 |
-
- 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.
- 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 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
6
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,
7
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 ●
8
- 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 Soft
Tissue Laser
Subject Device | Gemini 810 + 980 Diode
Laser
Primary Predicate | Epic Pro Diode Laser
System
Reference predicate
device |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Laser
Classification | IV (4) | IV (4) | IV (4) |
| | Gemini 2 810 + 980 Soft
Tissue Laser
Subject Device | Gemini 810 + 980 Diode
Laser
Primary Predicate | Epic Pro Diode Laser
System
Reference predicate
device |
| 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; or
980 ± 10nm; or
810nm and 980nm ±
10nm | 810 ± 10nm; or
980 ± 10nm; or
810nm and 980nm ±
10nm | 980nm ± 20nm |
| Average Output
Power | Adjustable 0.1 - 2 Watts | Adjustable 0.1 - 2 Watts | Adjustable 0.1 – 25.0 Watts |
| Max Peak Output
Power | 150 Watts | 20 Watts | 150 Watts |
| Increments of
Power Available | 0.1 Watts | 0.1 Watts | 0.2-1 Watts |
| Operating Voltage | 100-240 VAC | 100-240 VAC | 100V - 240V at
1.2A/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 Ion
Rechargeable | Lithium Ion
Rechargeable | None |
| Delivery System | Quartz glass fiber & tip | Quartz glass fiber & tip | Fiber optic cable,
handpiece and
disposable fiber tips |
| Fiber/Tip Diameter | 400 µm flexible fiber optic
cable | 400 µm flexible fiber optic
cable | 300 - 400 µm |
| Spot Size at Target | 400 µm diameter; 25mm
PBM Adapter, 7mm PBM
Adapter and 3mm PBM
Adapter | 400 µm diameter; 25mm
PBM 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 access
key | Wireless Foot Switch,
with electronic access
key | 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 Soft
Tissue Laser
Subject Device | Gemini 810 + 980 Diode
Laser
Primary Predicate | Epic Pro Diode Laser
System
Reference predicate
device |
| | components | components | electronic parts and
components |
| User
Interface | Electroluminescent
glass
display with capacitive
touch
interface. Capacitive
touch
is a hard plastic. | Electroluminescent
glass
display with capacitive
touch
interface. Capacitive
touch
is sticker overlay. | Color front graphical
user
interface with dead
front
capacitive touch
buttons. |
| Pre-Set
Procedures | Three different
categories –
Surgical, Non-Surgical
and
Pain Relief | Four different
categories -
General Dentistry,
Orthodontics, Hygiene
and
Pain Relief | Multiple pre-set
procedures |
| Product
Update
Connectivity | Software update
performed
via app over Wi-Fi
connection (wireless) | Software update
performed
via USB plugged into
computer (hardwire) | Software update
performed
via USB plugged into
computer (hardwire) |
| Haptic Feedback in
Foot Pedal | Yes | n/a | n/a |
9
10
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 ●
11
- 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
12
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.