MEDLITE C1 Q-SWITCHED ND:YAG LASER

K050696 · Hoya Photonics, Inc. · GEX · Jun 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050696
• Device Name: MEDLITE C1 Q-SWITCHED ND:YAG LASER
• Applicant: Hoya Photonics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedLite™ C1 Q-Switched Nd:YAG Laser is intended for: Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

Device Story

MedLite™ C1 Q-Switched Nd:YAG Laser is a medical laser system used in dermatology. It operates as a surgical instrument for soft tissue procedures and treatment of pigmented lesions. The device utilizes Q-switched Nd:YAG laser technology, specifically at 532 nm, to deliver energy for ablation, vaporization, incision, or excision. It is intended for use by healthcare professionals in clinical settings. The laser output allows physicians to perform dermatological procedures; the clinical benefit is the precise removal or treatment of targeted tissue or lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Q-switched Nd:YAG laser system; 532 nm wavelength; surgical laser instrument; Class II device; powered laser system.

Indications for Use

Indicated for patients requiring treatment of pigmented lesions or incision, excision, ablation, and vaporization of soft tissue in general dermatology.

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

• MedLite™ C3 Q-Switched Nd:YAG Laser (K050696)

Submission Summary (Full Text)

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JUN 17 2005

KA50696, p. 1 of 1

## 9. 510(k) Summary

| Company: | HOYA ConBio (formerly Continuum Electro-Optics, Inc.)<br>47733 Fremont Blvd<br>Fremont, CA 94538<br>[phone] phone<br>[phone] fax |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jim Green<br>Vice President of Engineering |
| Device Trade Name: | MedLite™ C1 Q-Switched Nd:YAG Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser |
| Classification Code: | 79-GEX |
| Equivalent Device(s): | MedLite™ C3 Q-Switched Nd:YAG Laser |
| Intended Use: | The MedLite™ C1 Q-Switched Nd:YAG Laser is intended for:<br>Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology |
| Comparison: | The MedLite™ C1 Q-Switched Nd:YAG Laser maintains the same<br>fundamental technology and intended uses (at 532 nm) as its<br>legally marketed predicate device, the MedLite™ C3 Q-Switched<br>Nd:YAG Laser. |
| Nonclinical Performance<br>Data: | None |
| Clinical Performance Data: | None |
| Additional Information: | None |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 2005

Mr. Jim Green Vice President of Engineering Hoya Photonics Incorporated 47733 Fremont Boulevard Fremont, California 94538

Re: K050696

Trade/Device Name: MedLite™ C' Q-Switched Nd: YAG Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 16, 2005 Received: March 21, 2005

Dear Mr. Green:

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 - Mr. Jim Green

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your arrantial equivalence of your device to a legally premarket notification. "The I DTC Intamged basification 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 If you desire specific acvice ior your acc [phone] . Also, please note the regulation entitled, Comact the Office of Comphalled at (21 the Part 807.97). You may obtain Misolanding by release to premainter to premainter the Act from the Division of Small other general information on your response 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,

R. A. M.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 6. Indications for Use Statement

510(k) Number:

K050696

Device Name:

MedLite™ C' Q-Switched Nd:YAG Laser

Indications for Use:

- Treatment of pigmented lesions .
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- Incision, excision, ablation, vaporization of soft tissue . for general dermatology
Prescription Use __ X (21 CFR 801 Subpart D)

OR

Over-the-Counter Use (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)

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K050696

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