REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR

K103118 · Hoya Photonics, Inc. · GEX · Nov 19, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K103118
• Device Name: REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
• Applicant: Hoya Photonics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 19, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology. Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Device Story

The RevLite Q-Switched Nd:YAG Laser System is an electrically powered surgical laser console. It delivers laser energy to tissue via an articulated arm, a handpiece adaptor, and specialized handpieces. The operator, typically a physician, controls laser emission using a footswitch. The system functions by emitting specific wavelengths (1064 nm, 532 nm, and optional 585/650 nm) to perform tissue incision, excision, ablation, vaporization, coagulation, and hemostasis. The handpiece adaptor facilitates the connection of various handpieces to the console. By targeting specific chromophores in the skin, the laser enables the treatment of pigmented and vascular lesions, tattoo removal, and skin resurfacing. The device is intended for use in clinical settings for dermatologic and general surgical procedures.

Clinical Evidence

No clinical performance data provided; bench testing only.

Technological Characteristics

Electrically powered laser console; articulated arm delivery system; handpiece adaptor; Q-switched Nd:YAG laser source; wavelengths: 1064 nm, 532 nm (nominal 585 nm and 650 nm with optional dye handpiece).

Indications for Use

Indicated for patients requiring dermatologic and general surgical procedures including incision, excision, ablation, and vaporization of soft tissue, coagulation, and hemostasis. Specific applications include tattoo removal (dark and light inks), treatment of dermal and epidermal pigmented lesions (e.g., Nevus of Ota, cafe-au-lait, lentigines), vascular lesions (e.g., port wine birthmarks, telangiectasias), hair removal, skin resurfacing for acne scars and wrinkles, and reduction of red pigmentation in hypertrophic and keloid scars.

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

• RevLite Q-Switched Nd:YAG Laser System (K083899)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification: Handpiece Adaptor RevLite Q-Switched Nd:YAG Laser System October 15, 2010

## 5. Special 510(k) Summary

Handpiece Adaptor Accessory for the RevLite Q-Switched Nd:YAG Laser System: Special 510k Summary

HOYA ConBio™

NOV 1 9 2010

" pl

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

Submitter:

HOYA Photonics, Inc. (dba HOYA ConBio, Inc.) 47733 Fremont Blvd. Fremont, California 94538 Phone: [phone] Fax: [phone]

Contact:

Donna K. Templeman Regulatory Consultant for HOYA ConBio, Inc.

October 15, 2010 Date Summary Prepared:

Device Trade Name:

RevLite Q-Switched Nd:YAG Laser System

Common Name: Dermatology Laser System

Instrument, surgical, powered, laser Classification Name: 79-GEX

878.4810 Laser surgical instrument for use in general and Classification Code: plastic surgery and in dermatology (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. ·

RevLite Q-Switched Nd:YAG Laser System (K083899) Equivalent Device:

Confidential

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Special 510(k) Premarket Notification: Handpiece Adaptor RevLite Q-Switched Nd:YAG Laser System October 15, 2010

The RevLite Q-Switched Nd:YAG Laser System with Device Description: Handpiece Adaptor consists of a electrically powered Console in which laser energy produced within the system is delivered to the tissue by means of an articulated arm, Handpiece Adaptor and specially designed Handpieces. The user activates laser emission by means of a footswitch. Incision, Excision, Ablation, Vaporization of Soft Tissue for Intended Use: General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Comparison: The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adapator is comparable to its parent predicate device (RevLite Q-Switched Nd:YAG Laser System with LCD) in terms of its intended use, indications for use, technical specifications, operating performance features, and general design features. Nonclinical Performance None Data: Clinical Performance Data: None Additional Information: None requested at this time.

Confidential

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

Hoya Photonics, Inc. % DKT Consulting Ms. Donna K. Templeman 1105 Sunset Creek Lane Pleasanton, California 94566

NOV 1 9 2010

Re: K103118

Trade/Device Name: RevLite Q-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 15, 2010 Received: October 21, 2010 ·

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. 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.

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Page 2 – Ms. Donna K. Templeman

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 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/Reportal?roblem/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,

For Dr. Dir

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

NOV 1 9 2010

Indications for Use Indications for Use
510(k) Number (if known): 103 118

Device Name: Handpiece Adaptor (HPA) RevLite Q-Switched Nd:YAG Laser System

Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology. Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

## Specific Indications:

- 1064 nm wavelength .
- Tattoo Removal (dark ink: blue and black) .
- Dermal Pigmented Lesions .
- . Nevus of Ota
- Removal or lightening of hair with or without adjuvant preparation. ♥
- Skin Resurfacing for Acne Scars and Wrinkles .
- Benign cutaneous lesions, such as, but not limited to: striae and scars . excludes the 650nm wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where . vascularity is an integral part of the scar (excludes the 650nm wavelength)

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

- Tattoo removal (light ink: red, sky blue, green) .
- Vascular lesions including but not limited to: port wine birthmarks, . telangiectasias, spider angioma, cherry angioma, spider nevi
- Epidermal Pigmented lesions including but not limited to: cafe-au-lait . birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
- . Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions, such as, but not limited to: striae and scars . (excludes the 650nm wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where . vascularity is an integral part of the scar (excludes the 650nm wavelength)

Prescription Use × 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)

(Division Sign-Off)

Divisionofistanical Orthanddoffice of Device Evaluation (ODE) and Restorative Devices

Restorative Devices

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Confidential

510(k) Number K103118