EMVERA DIOLUX

K123257 · Emvera Technologies, Inc. · GEX · Dec 14, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K123257
• Device Name: EMVERA DIOLUX
• Applicant: Emvera Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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. 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 Story

Emvera Diolux is a pulsed 808nm diode laser system for dermatological treatments. Device consists of a main control unit with a visual color LCD interface and a handpiece for laser irradiation. Operator (physician or under physician order) uses the system to deliver stable, uniform laser pulses to the skin. Output parameters include fluence up to 120 J/cm², pulse duration 5-625 ms, and repetition rates of 1-10 Hz depending on mode. System utilizes water cooling. Clinical benefit includes hair removal/reduction and treatment of vascular/pigmented lesions. Device is intended for clinical use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, electrical safety, and biocompatibility testing, alongside a comparative analysis of technical specifications against the predicate device.

Technological Characteristics

808nm pulsed diode laser; 12.0 mm square spot size; water cooling system; 26 kg weight; 120/230V power input. Interface includes direct visual color LCD screen with operator prompts. Electrical safety and biocompatibility requirements met.

Indications for Use

Indicated for hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions in patients. Note: potential for increased hair growth in females of Mediterranean, Middle Eastern, and South Asian heritage when treated on face and neck.

Regulatory Classification

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.

Predicate Devices

• Soprano XL (K102716)

Submission Summary (Full Text)

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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: [phone]

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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## 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.

### Indications for Use

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

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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.

## Safety Testing

Electrical Safety Testing and Biocompatibility requirements have been met.

| Parameters | Emvera Diolux | Alma Lasers, Inc.<br>Soprano XL |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K102716 |
| Indications for Use | The Emvera Diolux is<br>indicated for hair<br>removal, permanent hair<br>reduction and for the<br>treatment of benign<br>vascular and pigmented<br>lesions. | The Diode Laser Module:<br>The HR Mode is intended<br>for hair removal,<br>permanent hair reduction.<br>The LaserBlanche Mode<br>is intended for the<br>treatment of benign<br>vascular and pigmented<br>lesions. |
| 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 2<br>1-3 Hz DP 1<br>5-10 Hz FDP Mode | 1-3 Hz Pulse Mode<br>1-10 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 50/60<br>Hz | 120/230V 20/10 A 50/60<br>Hz |

# 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).

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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.

.

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#### 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 [phone] or [phone] 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.

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.

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

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