Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Hair removal by laser or IPL sources can cause increase hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.

Caution: Federal (USA) law restricts this device for use by or on the order of a physician.

Device Description

This laser operation equipment is a diode laser of 808nm of pulsed diode laser.

This equipment is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to be use in various treatments by effecting the skin by laser beam of 808nm.

Diode laser of 808nm is able to transfer stable and uniform pulses to skin, therefore operator can treat patient safely and effectively using this equipment. This equipment provides direct visual color LCD screen configured with prompts for ease of use for the operator.

AI/ML Overview

The provided text is a 510(k) summary for the Emvera Diolux Surgical Laser. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain any information about a study that proves the device meets specific acceptance criteria through performance evaluation.

The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (Alma Lasers, Inc. Soprano XL) based on similar product characteristics and indications for use. This regulatory pathway does not typically require the submission of new clinical efficacy studies with predefined acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, for aspects of your request related to acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone performance), and ground truth establishment for this specific device's 510(k) submission, the provided document does not contain this information.

The document essentially states:

"Based on the comparisons found in the predicate product comparison table no new issues of safety and effectiveness are raised in this original new 510(k). This conclusion is based on the fact that the Emvera Diolux and the Alma Lasers Soprano XL have the same as or similar product characteristics, such as laser type, wave length, flounce, mode, duration, repetition, spot size, cooling and power input."

This indicates that the acceptance criteria are implicitly met by being "substantially equivalent" to a legally marketed predicate device, rather than through a new, independent performance study against defined metrics.

Summary of Information Present/Absent based on your request:

A table of acceptance criteria and the reported device performance:
- Absent. The document does not define specific performance acceptance criteria for the Emvera Diolux or report its performance against such criteria. It provides a table comparing technical specifications of the Emvera Diolux and the predicate device.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Absent. No test set or study data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Absent. No test set or ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Absent. No test set or adjudication process is described.
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:
- Absent. This device is a laser surgical instrument, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device and was not conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Absent. Not applicable to this type of medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Absent. No ground truth is described as no performance study was detailed.
The sample size for the training set:
- Absent. No training set is described.
How the ground truth for the training set was established:
- Absent. No training set or ground truth establishment is described.

In essence, this 510(k) submission relies on device comparison and shared indications for use for regulatory clearance, not on a new, independent clinical performance study.

Summary

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510(k) Summary

Summary Preparation Date:

August 23, 2011

123257

Company:

Emvera Technologies, LLC. 641 10th Street Cedartown, GA 30125

Contact Information:

770-749-1530 Phone: Fax: 888-361-7636

Contact Person:

Lyle Fuller

Device Name: Common/Usual Name: Classification Name: Requlation Number: Product Code: Device Class: Review Panel:

Emvera Diolux Surgical Laser Powered Laser Surgical Instrument 21 CFR 878.4810 GEX Class II Division of General, Restorative and Neurological Devices

Predicate Device:

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Company of Concession College of Concession Company of Concession Company of Children Company of Children Company of Children Company of Children Company of Children CompanyCompany of Canada Company of Children Company of Children Company of Children Company Come of Children Company of Children Company of Children Company of Children Company Com	onrano	1400740

Device Description

This laser operation equipment is a diode laser of 808nm of pulsed diode laser.

Indications for Use

The Emvera Diolux is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.

{1}------------------------------------------------

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Caution: Federal (USA) law restricts this device for use by or on the order of a physician.

Safety Testing

Electrical Safety Testing and Biocompatibility requirements have been met.

Parameters	Emvera Diolux	Alma Lasers, Inc.Soprano XL
510(k) Number		K102716
Indications for Use	The Emvera Diolux isindicated for hairremoval, permanent hairreduction and for thetreatment of benignvascular and pigmentedlesions.	The Diode Laser Module:The HR Mode is intendedfor hair removal,permanent hair reduction.The LaserBlanche Modeis intended for thetreatment of benignvascular and pigmentedlesions.
Laser Type	Laser Diode	AlGaAs Diode / CW
Wave Length	808nm	800nm
Fleunce	Up to 120 J/cm²	Up to 120 J/cm²
Mode	Pulsed	Pulsed
Duration	5-625 ms	10-1,350 ms
Repetition	1-2 Hz DP 21-3 Hz DP 15-10 Hz FDP Mode	1-3 Hz Pulse Mode1-10 Hz SHR Mode
Spot Size	12.0 mm (Square)	12 x 10 mm (Square)
Cooling	Water Cooling	Dual Chill
Weight	26 Kg	27 Kg
Power Input	120/230V 20/10 A 50/60Hz	120/230V 20/10 A 50/60Hz

Predicate Product Comparison

Based on the comparisons found in the predicate product comparison table no new issues of safety and effectiveness are raised in this original new 510(k).

{2}------------------------------------------------

This conclusion is based on the fact that the Emvera Diolux and the Alma Lasers Soprano XL have the same as or similar product characteristics, such as laser type, wave length, flounce, mode, duration, repetition, spot size, cooling and power input.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

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

Letter dated: December 14, 2012

Emvera Technologies, Incorporated % Smith Associates Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062

Re: K123257

Trade/Device Name: Emvera Diolux 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: October 16, 2012 Received: October 18, 2012

Dear Mr. Devine:

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

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Page 2 - Mr. Ned Devine

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

Indications for Use

510(k) Number K123257

Emvera Diolux

Indications for Use:

The Emvera Diolux is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Caution: Federal (USA) law restricts this device for use by or on the order of a physician.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Neil R Ogden 2012.12.04 ¸09:05:08 -05'00'

(Division Sign-off) for MXM Division of Surgical Devices 510(k) Number

Page 1 of 1

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.