REVLITE Q-SWITCHED ND:YAG LASER

K063112 · Hoya Conbio, Inc. · GEX · Dec 1, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063112
• Device Name: REVLITE Q-SWITCHED ND:YAG LASER
• Applicant: Hoya Conbio, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in dermatology for the following indications: Treatment of Epidermal Pigmented Lesions, Treatment of Dermal Pigmented Lesions Nevus of Ota, Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis, Laser skin resurfacing procedures for the treatment of acne scars and wrinkles, Tattoo Removal: Dark Ink: (Black & Blue) Light Ink: (Red, Sky Blue, Green), Treatment of Vascular Lesions, Removal or lightening of unwanted hair with or without adjuvant preparation

Device Story

RevLite Q-Switched Nd:YAG laser system; console-based unit; delivers laser energy via articulated arm with MultiSpot or optional Multilite Dye Laser handpieces. Physician-operated in clinical settings. Device emits 1064 nm wavelength (or 532/585/650 nm via dye handpiece) to target tissue for surgical, dermatological, or aesthetic applications. User activates emission via footswitch. System design allows higher energy delivery over larger spot sizes at equivalent fluence, facilitating faster treatment of larger areas. Output enables tissue destruction, coagulation, or pigment/hair removal, aiding clinical management of lesions, scars, and unwanted hair.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Q-Switched Nd:YAG laser system; 1064 nm wavelength (nominal 585/650 nm via optional dye handpiece); articulated arm delivery; footswitch activation; console-based; electrical power source.

Indications for Use

Indicated for patients requiring dermatological or general surgical procedures including incision, excision, ablation, vaporization of soft tissue, coagulation, hemostasis, tattoo removal, hair removal, skin resurfacing for acne scars/wrinkles, and treatment of vascular or pigmented lesions.

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

• Focus Medical NaturaLase 1064 2 Joule Laser System (K# Unknown)
• MedLite C6 Q-Switched Nd: YAG Laser System (K014234)

Submission Summary (Full Text)

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K063112

# RevLite Q-Switched Laser System 510k Summary

DEC - 1 2006

Image /page/0/Picture/4 description: The image shows the logo for HOYA ConBio, with the words "HOYA" and "ConBio" in a bold, sans-serif font. Underneath the logo is the address "47733 Fremont Boulevard, Fremont, California 94538". The logo and address are in black text on a white background. The logo is horizontally aligned.

47733 Fremont Boulevard, Fremont, California 94538
510-445-4500 www.conbio.com 510-445-4550 Fax

| Submitter: | Hoya ConBio, Inc.<br>47733 Fremont Blvd.<br>Fremont, California 94538<br>Phone: [phone]<br>Fax: [phone] |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Donna K. Templeman<br>Regulatory Consultant |
| Date Summary Prepared: | July 31, 2006 |
| Device Trade Name: | RevLite™ Q-Switched Nd: YAG Laser System |
| Common Name: | Dermatology Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX |
| Classification Code: | 878.4810 Laser surgical instrument for use in general and plastic<br>surgery and in dermatology (1) A carbon dioxide laser for use in<br>general surgery and in dermatology is a laser device intended to<br>cut, destroy, or remove tissue by light energy emitted by carbon<br>dioxide.<br>(2) An argon laser for use in dermatology is a laser device<br>intended to destroy or coagulate tissue by light energy emitted by<br>argon. |
| Equivalent Device: | Focus Medical NaturaLase 1064 2 Joule Laser System - K#<br>Unknown<br>MedLite C6 Q-Switched Nd: YAG Laser System - K014234 |
| Device Description: | The RevLite System laser unit and controls are contained in a<br>single console. Electrical power is supplied to the console by the<br>facility's power source. Laser energy produced within the device<br>is delivered to the tissue by means of an articulated arm and a<br>specially designed MultiSpot Handpiece or optional Multilite Dye<br>Laser Handpieces. The user activates laser emission by means of<br>a footswitch. The RevLite System incorporates 2 very narrow<br>laser applications designed to apply more energy over a larger |

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063112

spot size at the same fluence level, enabling the physician to treat a larger area more rapidly.

| Intended Use: | For use in dermatology for the following indications: Treatment<br>of Epidermal Pigmented Lesions, Treatment of Dermal<br>Pigmented Lesions Nevus of Ota, Incision, Excision, Ablation,<br>Vaporization of Soft Tissue for General Dermatology,<br>Dermatologic and General Surgical Procedures for Coagulation<br>and Hemostasis, Laser skin resurfacing procedures for the<br>treatment of acne scars and wrinkles, Tattoo Removal: Dark Ink:<br>(Black & Blue) Light Ink: (Red, Sky Blue, Green), Treatment of<br>Vascular Lesions, Removal or lightening of unwanted hair with or<br>without adjuvant preparation |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The RevLite Laser System is comparable to its predicate and<br>parent devices in terms of its indications for use, technical<br>specifications, operating performance features, and general design<br>features. |
| Nonclinical Performance<br>Data: | None |
| Clinical Performance Data: | none |
| Additional Information: | None requested at this time. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Iloya ConBio % Ms. Donna K. Templeman Regulatory Consultant . 47733 Fremont Boulevard Fremont, California 94538

DEC = 1 2006

Re: K063112

Trade/Device Name: Revlite O-Switched Nd: YAG Laser System 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 31, 2006 Received: November 2, 2006

Dear Ms. Templeman:

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 such 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); 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.

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Page 2 - Ms. Donna K. Templeman

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours

P.M. Nhm

Mark N. Melkerson Director Division of General, Restorative and Neurological 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): K063112

#### RevLite Q-Switched Nd: YAG Laser System Device Name;

### Indications for Use:

The RevLite Q-Switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatology, Dermand General Surgical Procedures for Coagulation and Hemostasis.

### Specific Indications:

# 1064 nm wavelength:

Tattoo Removal: Dark Ink: (Black & Blue)

Nevus of Ota

Removal or lightening of unwanted hair with or without adjuvant preparation.

Skin resurfacing procedures for the treatment of acne scars and wrinkles

532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece):

Tattoo Removal: Light Ink (Red, Sky Blue, Green)

Treatment of Vascular Lesions including, but not limited to:

- port wine birthmarks
- . telangiectasias
- spidcr angioma
- . cherry angioma
- � spider nevi

Treatment of Pigmented Lesions including, but not limited to:

- . cafe-au-lait birthmarks
- . solar lentiginos
- . senile lentiginos
- Becker's nevi
- Freckles

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- Nevus spilus ◆
Skin resurfacing procedures for the treatment of acne scars and wrinkles

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODF)

Page ___olie

(Posted November 13, 2003)

R.N. Ohri

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** k063112