TRIA HAIR REMOVAL LASER SYSTEM

K090820 · Spectragenics, Inc. · GEX · Dec 23, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090820
• Device Name: TRIA HAIR REMOVAL LASER SYSTEM
• Applicant: Spectragenics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

Device Story

TRIA is a semiconductor diode laser system; delivers infrared light at 800 nm wavelength. Designed for over-the-counter (OTC) use by consumers for hair removal and permanent reduction in hair regrowth. Device functions as an adjunct to shaving; requires periodic treatment sessions. User operates device directly on skin; laser energy targets hair follicles to achieve long-term, stable reduction in hair counts. Benefits include convenient home-based hair management and sustained hair reduction results.

Clinical Evidence

Clinical trials conducted to demonstrate safety and efficacy for OTC use for hair removal and permanent reduction in hair regrowth. Specific metrics and study details not provided in the summary text.

Technological Characteristics

Semiconductor diode laser system; infrared light output at 800 nm nominal wavelength. Handheld form factor for OTC use.

Indications for Use

Indicated for over-the-counter hair removal in conjunction with shaving and for permanent reduction in hair regrowth via periodic treatment regimes.

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

• SpectraGenics Spectra Hair Removal Laser System (K053527)
• Star Medical Technologies LightSheer Pulsed Diode Array Laser System (K982940)
• Home Skinovations Flash N' Go (K082298)

Submission Summary (Full Text)

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## TRIA Laser Hair Removal System (TRIA)

# 12090820

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

TRIA Beauty, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588-8552 Phone: [phone] Facsimile: 925-701-2598 Contact Person: Lisa D. Parr, Pharm.D. Date Prepared: December 7, 2009

### Name of Device and Name/Address of Sponsor

TRIA Laser Hair Removal System (TRIA) TRIA Beauty, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588-8552

#### Common or Usual Name

Pulsed Diode Laser

### Classification Name

Laser Instrument, Surgical, Powered Regulation Number: 21 C.F.R.§ 878.4810 Product Code: GEX

### Predicate Devices

SpectraGenics Spectra Hair Removal Laser System (K053527) Star Medical Technologies LightSheer Pulsed Diode Array Laser System (K982940) Home Skinovations Flash N' Go (K082298)

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#### Intended Use / Indications for Use

TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

## Technological Characteristics

TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.

#### Performance Data

Clinical trials have been conducted to demonstrate the safety and efficacy of TRIA for over-the-counter use for hair removal sustained with periodic treatments and for permanent reduction in hair regrowth.

## Substantial Equivalence

TRIA has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. Any minor differences between the TRIA and its predicate devices raise no new questions of safety or effectiveness nor change the device's intended therapeutic effect in comparison to its predicates. Performance data demonstrate that TRIA is as safe and effective as its predicate devices for the stated indications. Thus, TRIA is substantially equivalent.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 2 3 2009

TRIA Beauty, Inc. % Tobin C. Island, Ph.D. Executive Vice President 5880 W. Las Positas Boulevard, Suite 52 Pleasanton, California 94588

Re: K090820

Trade/Device Name: TRIA Laser Hair Removal System (TRIA) 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: December 7, 2009 Received: December 7, 2009

Dear Dr. Island:

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Tobin C. Island, Ph.D.

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/ucm1.15809.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/cdrh/mdr/ 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 ne mber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Toh
Mark N. Melkerson
Daef D.M

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K090820

Device Name: TRIA Laser Hair Removal System (TRIA)

Indications for Use: -

TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Surgical, OrthopedicPage of and Restorative Devices

510(k) Number /K090820

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