· Excisional and incisional biopsies
· Exposure of unerupted teeth
Fibroma removal
· Gingivoplasty
· Hemostasis and coagulation
· Incision and drainage of abscess
· Operculectomy
· Pulpotomy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Vestibuloplasty
· Laser Soft Tissue Curettage
· Tissue retraction
Frenectomy and Frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingival incision and excision
· Implant recovery
· Leukoplakia
· Oral papillectomnies
Pulpotomy as an adjunct to root canal therapy
· Reduction of bacterial level (decontamination) and inflammation
Treatment of aphthous ulcers
· Lesion (tumor) removal
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Removal of Diseased, Inflamed and necrotic 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 necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

· Light activation for bleaching materials for teeth whitening
· Laser-assisted whitening/bleaching of teeth

Device Description

The ELUMI 810 + 980 Soft Tissue Laser, or ELUMI, is a battery-powered counter top surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental teeth whitening.

The ELUMI comprises of five main assemblies; of a Laser Unit, a flexible fiber delivery system tethered to an anodized aluminum hand piece, disposable single-use fiber tips, a wireless footswitch, and an auxiliary power supply. Infrared laser energy is emitted from the fiber tips when the wireless footswitch is depressed. The ELUMI Laser Unit contains two single-emitter solid-state laser diodes of 10.0-watt peak output power each (Class IV laser), one lasing at 810nm and the other at 980nm wavelength. The laser diodes can simultaneously emit laser energy when ELUMI is set to Dual Wavelength mode. The laser diodes are directly coupled to the flexible fiber optic cable that connects the Laser Unit to the surgical hand piece and disposable fiber tip that emits the energy to the target area. The system also contains a 5mW power, 650nm laser diode coupled to the same fiber optic cable to produce the red aiming light. The laser's visible light is designed to aid the clinician in aiming the tip of the delivery fiber onto the target tissue. Additionally, a bright white light from two LEDs in the hand piece illuminates tarqet tissue during procedures through the translucent disposable laser tips. The auxiliary power supply connects to the Laser Unit and is used to charge the system battery and as a power source for the system in the event of low battery capacity.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ELUMI 810 + 980 Soft Tissue Laser, claiming substantial equivalence to a predicate device, the QuickLase DUAL+. As such, the study performed is a comparative effectiveness study against a predicate device rather than a standalone study establishing de novo acceptance criteria and performance thresholds.

The primary goal of the submission is to demonstrate that the new device is "as safe and as effective" as the predicate device. Therefore, the "acceptance criteria" can be implicitly understood as showing comparable performance to the predicate device in key functional and safety aspects.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission seeking substantial equivalence to a predicate device, the "acceptance criteria" are generally based on meeting or demonstrating comparable performance to the legally marketed predicate device (QuickLase DUAL+) and compliance with relevant international standards. The performance reported focuses on demonstrating this equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance (ELUMI 810 + 980 Soft Tissue Laser)
Safety:
Adherence to Laser Safety Standards	Complied with 21 CFR 1040.10 & 1040.11 (except for deviations per laser notice 50), IEC 60601-2-22, and IEC 60825-1.
Adherence to Electrical Safety Standards	Complied with AAMI/ANSI ES60601-1 and IEC 60601-1-2.
Biocompatibility	Complied with AAMI/ANSI/ISO 10993-5:2009 (cytotoxicity).
Cleaning Validation (for reusable components)	Anodized Aluminum Surgical Hand Piece with Fiber Connector achieved 78.5% and 77.6% recoveries for protein and hemoglobin respectively. Cleaned devices contained < 5.4 μg/cm² protein and < 1.6 µg/cm² hemoglobin, validating the cleaning procedure.
Sterilization Validation (for reusable components)	Validated a 15-minute gravity steam sterilization cycle at 135°C for the Anodized Aluminum Hand Piece Shell, achieving a 10-6 sterility assurance level (SAL).
Effectiveness/Performance:
Comparable Average Power Output to Predicate (within limits)	Bench testing demonstrated that the ELUMI's average output power varied by less than ±20% of the setting, satisfying IEC 60601-2-22, similar to the Predicate Device.
Comparable Features and Functions to Predicate	Bench testing found ELUMI substantially equivalent to the Predicate Device by having identical features and functions as identified in 21 CFR 1040.10.
Comparable Histological Effects on Soft Tissue to Predicate	An animal study on pig liver soft tissue showed that the ELUMI 810+980 Soft Tissue Laser and the Predicate Device had "similar effects on soft tissue."
Equivalent Indications for Use to Predicate Device	Indications for use are explicitly stated as "identical to those of the previously cleared Predicate Device."
Equivalent Technological Characteristics to Predicate Device	Key technological characteristics (laser type, medium, wavelengths, max peak power, pulse type, delivery system, fiber diameter, aiming beam, activation) are largely identical or equivalent, as detailed in the "Technological Characteristics" table. Minor differences do "not alter the fundamental scientific technology."
Equivalent Functional Characteristics to Predicate Device	Functional characteristics (indications for use, operating principle, basic construction, shelf life, packaging) are identical or similar.

2. Sample Size Used for the Test Set and Data Provenance

Bench Testing: The sample size for bench testing of power output, features, and functions is not explicitly stated. It implies multiple measurements to ensure compliance.
Animal Study: The sample size for the animal study is not specified in the provided text. It only states "an animal study was conducted."
Data Provenance: The data for bench testing and the animal study would be prospective experiments conducted by the manufacturer for this 510(k) submission. The country of origin for the data is not explicitly stated but is likely the location where Azena Medical, LLC operates or commissioned the tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This 510(k) submission primarily relies on bench test data, compliance with recognized standards, and animal study results to demonstrate substantial equivalence to a predicate device. There is no mention of human experts defining a "ground truth" for a specific test set in the context of diagnostic accuracy, which is where such experts would typically be involved.

4. Adjudication Method for the Test Set

N/A. As stated above, this submission relies on objective measurements in bench tests and observations from an animal study, not human interpretation of a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is a surgical laser, and the "comparative effectiveness" is demonstrated through physical property measurements and biological effect studies against a predicate device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, in a sense. The bench testing and animal study represent "standalone" evaluations of the device's physical properties and biological effects without human intervention influencing the fundamental laser mechanism. The compliance with standards and the performance of the device itself (e.g., power output, histological effects) are assessed independently.

7. Type of Ground Truth Used

Bench Testing: The "ground truth" is defined by international and national standards (e.g., IEC 60601-2-22 for power output deviation) and direct comparison to the physical and functional characteristics of the predicate device.
Animal Study: The "ground truth" for histological effects would be derived from histopathological analysis of tissue samples, likely performed by veterinary pathologists, comparing the effects of the test device to the predicate device.

8. Sample Size for the Training Set

N/A. This device is a hardware laser system, not an AI/ML algorithm that requires a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

N/A. See point 8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them that resemble a bird in flight. The profiles are stacked, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 16, 2015

Azena Medical, LLC % Mr. Dave Yungvirt Third Party Review Group, LLC 45 Rockefeller Plaza Suite 2000 New York, New York 10111

Re: K152032

Trade/Device Name: ELUMI 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: GEX Dated: August 27, 2015 Received: September 1, 2015

Dear Mr. Yungvirt:

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. 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152032

Device Name ELUMI 810 + 980 Soft Tissue Laser

Indications for Use (Describe)

The indications for use are identical to those of the previously cleared Predicate Device. The ELUMI 810+980 Soft Tissue Laser is intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue.

The following are the oropharyngeal indications for use:

· Excisional and incisional biopsies
· Exposure of unerupted teeth
Fibroma removal
· Gingivoplasty
· Hemostasis and coagulation
· Incision and drainage of abscess
· Operculectomy
· Pulpotomy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Vestibuloplasty
· Laser Soft Tissue Curettage
· Tissue retraction
Frenectomy and Frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingival incision and excision
· Implant recovery
· Leukoplakia
· Oral papillectomnies
Pulpotomy as an adjunct to root canal therapy
· Reduction of bacterial level (decontamination) and inflammation
Treatment of aphthous ulcers
· Lesion (tumor) removal
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Removal of Diseased, Inflamed and necrotic soft tissue within the periodontal pocket
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium

· Light activation for bleaching materials for teeth whitening
· Laser-assisted whitening/bleaching of teeth

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Traditional 510(k)

Section 5 510(k) Summary

510(k) Summary of Safety and Effectiveness

Traditional 510(k) Premarket Notification

Submitter:

Azena Medical, LLC 21 Massolo Dr, 2nd Floor – Unit C Pleasant Hill, CA 94523

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.

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

Submitter:	Azena Medical, LLC21 Massolo DriveFI2 Unit CPleasant Hill, CA 94523
Contact Person:	Alexandre B. Di SessaFounder & CEOPhone: 800-466-5273Email: 510k@azenamedical.com

Date of Preparation: April 6, 2015
1. Name of device, including the trade name and classification name:

Trade Name:	ELUMI 810 + 980 Soft Tissue Laser
Common Name(s):	Diode laser, powered laser surgical instrument
Classification Name(s):	Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulation Number:	§878.4810

Device Class: Class II for all requested indications

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Product Code: GEX

Classification Panel: General and Plastic Surgery & Others

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

Predicate Device:

Company:	QuickLase Limited
Device:	QuickLase DUAL+
510(k):	K100474
Date Cleared:	March 16, 2010

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 ELUMI 810 + 980 Soft Tissue Laser, or ELUMI, is a battery-powered counter top surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental teeth whitening.

Statement of intended use: 5.

The indications for use are identical to those of the previously cleared Predicate Device.

The ELUMI 810+980 Soft Tissue Laser is intended for the incision, excision, ablation,

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vaporization, hemostasis, and treatment of oral soft tissue.

The following are the oropharyngeal indications for use:

. Excisional and incisional biopsies
. Exposure of unerupted teeth
. Fibroma removal
Gingivoplasty
. Hemostasis and coaqulation
. Incision and drainage of abscess
. Operculectomy
. Pulpotomy
. Reduction of gingival hypertrophy
. Soft tissue crown lengthening
Vestibuloplasty
. Laser Soft Tissue Curettage
. Tissue retraction
. Frenectomy and Frenotomy
. Gingival troughing for crown impressions
Gingivectomy
. Gingival incision and excision
Implant recovery
. Leukoplakia
Oral papillectomnies
. Pulpotomy as an adjunct to root canal therapy
. Reduction of bacterial level (decontamination) and inflammation
Treatment of aphthous ulcers
Lesion (tumor) removal
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
. Removal of Diseased, Inflamed and necrotic 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 necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)
Light activation for bleaching materials for teeth whitening .
Laser-assisted whitening/bleaching of teeth ●

6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:

The proposed ELUMI 810 + 980 Soft Tissue Laser has the following technological similarities

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to the Predicate Device:

the same laser type: solid state diode,
the same laser medium: GaAlAs,
. the same working beam wavelengths: 810nm or 980nm, dual wavelength (810nm + 980nm),
the same average power output up to 2.0 Watts,
. the same increments of average power available: 0.1 Watts,
. the same maximum peak output power: 10 Watts @ 810nm, 10 Watts @ 980nm, 20 Watts @ Dual Wavelength,
. the same pulse type: gated,
. the same delivery system and fiber diameter: 400 µm quartz glass fiber,
the same cutting method: tissue contact,
the same patient contacting components: quartz glass fiber,
. the equivalent user interface, and
the same activation means: foot switch.

7. Statement of how the functional characteristics of the device compare to those of the predicate or legally marketed device:

The proposed ELUMI 810 + 980 Soft Tissue Laser has the following functional similarities to the Predicate Device:

the same indications for use,
. the same operating principle,
the same basic construction,
. the same shelf life, and
. the same packaging materials and processes.

8. Performance Data:

The ELUMI 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

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IEC 60601-2-22
IEC 60825-1
. AAMI/ANSI ES60601-1
. IEC 60601-1-2
AAMI/ANSI ST81:2004/(R)2010
AAMI/ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013
. AAMI/ANSI/ISO 17665-1:2006
. AAMI/ANSI/ISO 17665-2:2009
AAMI/ANSI/ISO 10993-5:2009

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 ‍μg/cm² and < 1.6 µg/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.

Bench testing was performed to measure the ELUMI 810 + 980 Soft Tissue Laser's average output power side-by-side with the Predicate Device. The intended performance of these devices, based on IEC 60601-2-22, requires that the laser average power output only vary from the device's settings by less than ±20% of the setting. The results of the bench testing demonstrate that both the ELUMI 810 + 980 Soft Tissue Laser and the Predicate Device satisfy this IEC 60601-2-22 requirement.

Bench testing was also conducted to compare features and functions of the ELUMI 810+980 Soft Tissue Laser to the Predicate Device, and found that ELUMI is substantially equivalent to the Predicate Device by having identical features and functions as identified in 21 CFR 1040.10.

Additionally, an animal study was conducted to evaluate the histological effects on pig liver soft tissue of the Elumi 810+980 Soft Tissue Laser system, and compare the results to those of the Predicate Device. The results of this new animal study demonstrate that the Elumi 810+980

{9}------------------------------------------------

Soft Tissue Laser and the Predicate Device have similar effects on soft tissue, despite slight differences in average output power and operation modes.

This performance data, along with conformity to the recognized national and international standards cited above, demonstrates that the ELUMI 810 + 980 Soft Tissue Laser is as safe and as effective as its Predicate Device.

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

Technological Characteristics: 9.

The ELUMI 810 + 980 Soft Tissue Laser has the same fundamental technological characteristics as the Predicate Device.

	ELUMI 810 + 980 SoftTissue Laser	QuickLase DUAL+
Laser Classification	IV (4)	IV (4)
Type of Laser	Diode Laser	Diode Laser
Laser Medium	GaAIAs	GaAIAs
Wavelength	810 ± 10nm; or980 ± 10nm; or810nm and 980nm ±10nm	810 ± 10nm; or980 ± 10nm; or810nm and 980nm ±10nm
Average OutputPower	Adjustable 0.1 - 2 Watts	Adjustable 0.1 - 10 Watts
Max Peak OutputPower	10 Watts @ 810nm;10 Watts @ 980nm;20 Watts @ 810nm +980nm	10 Watts @ 810nm;10 Watts @ 980nm;20 Watts @ 810nm +980nm
Increments ofPower Available	0.1 Watts	0.1 Watts
Operating Voltage	100-240 VAC	100-240 VAC
Current Frequency	50-60 HZ	50-60 HZ
Operation Mode	Pulsed	Continuous, Pulsed
Pulse Type	Gated	Gated
Battery	Lithium Ion Rechargeable	Lithium Ion Rechargeable
Delivery System	Quartz glass fiber & tip*	Quartz glass fiber
Fiber/Tip Diameter	400 μm core	400 μm core
Fiber Aiming Beam	5mW laser diode, 650nm,Class 1	5mW laser diode, 645nm,Class 1
Activation Means	Wireless Foot Switch,with electronic access key	Wired Foot Switch, withelectronic access key

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Traditional 510(k)

*The quartz glass fiber within ELUMI's single-use fiber tip is the only system component that comes in direct or indirect contact with patients. This fiber is exactly the same fiber, sourced from the same supplier, and used in the same manner as the fiber used with another FDA cleared dental soft tissue laser, the SL3 (K102639).

Conclusions: 10.

The ELUMI 810 + 980 Soft Tissue Laser has the equivalent indications for use and technological characteristics as that of the Predicate Device. The minor technological differences that exist between the ELUMI 810 + 980 Soft Tissue Laser and its predicate devices do not alter the fundamental scientific technology of the device and raise no new questions of safety or effectiveness. Performance data demonstrates that the ELUMI 810 + 980 Soft Tissue Laser is as safe and as effective as its Predicate Device.

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.