LIGHT AGE Q-CLEAR LASER, MODEL 701-1101

K033259 · Light Age, Inc. · GEX · Feb 25, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033259
• Device Name: LIGHT AGE Q-CLEAR LASER, MODEL 701-1101
• Applicant: Light Age, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Light Age Q-Clear™ Laser is intended for the following uses: 1. For incision, excision, ablation, and vaporization of soft tissue for General Dermatology 2. The 1064nm wavelength is indicated for: Dark ink tattoo removal - Treatment of pigmented lesions (particularly Nevus of Ota) - Removal or lightening of hair - Skin resurfacing with or without adjuvant preparation : Treatment of common nevi -- 3. The 532nm wavelength is indicated for: Removal of light ink (red, tan, purple and orange) tattoos ー Treatment of common nevi - Treatment of café-au-lait spots - Treatment of seborrheic kcratoses - Treatment of vascular lesions, including facial and leg veins, telangiectasias, : angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)

Device Story

Nd:YAG laser system; emits 1064nm pulsed energy; optional frequency doubler enables 532nm emission. Laser energy delivered via handpiece to target area; produces circular beam on skin. Red aiming beam assists operator in targeting. Used in clinical dermatology settings by trained professionals. Device facilitates soft tissue surgery, tattoo removal, pigmented/vascular lesion treatment, and skin resurfacing. Safety features conform to 21CFR Part 1040.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Nd:YAG crystal rod lasing medium; 1064nm wavelength (near-infrared) with optional 532nm frequency doubler. Class IV laser product. Handpiece delivery with red aiming beam. Safety features per 21CFR Part 1040.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, or vaporization in dermatology; removal of dark ink tattoos (1064nm); removal of light ink tattoos (532nm); treatment of pigmented lesions (Nevus of Ota, café-au-lait spots, lentigines, ephelides); hair removal/lightening; skin resurfacing; treatment of common nevi, seborrheic keratoses, and vascular lesions (veins, telangiectasias, angiomas, hemangiomas, port wine stains).

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

• Palomar Q-Y AG™ Nd:YAG Laser System (K023967)
• Medlite™ Q-Switched Nd:YAG Laser (K022709 & K983054)
• Medlite™ C3 Q-Switched Nd:YAG Laser (K011677)
• Medlite™ C6 Q-Switched Nd:YAG Laser (K014234)
• Spectra-VRM Q-Switched Nd:YAG Laser System (K000317)

Submission Summary (Full Text)

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FEB 2 5 2004

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## LIGHT AGE, INC.

#### 510(k) Summary of Safety and Effectiveness Light Age Q-Clear™ Laser

In accordance with the Safe Medical Devices Act of 1990, 21CFR 807.92, the Following is a In accordance with the Sale Medical Devises information on which the substantial equivalence determination is based.

The safety and effectiveness of the Light Age Q-Clear™ Laser derives from a The safety and crecerveness of the predicate to the predicate devices listed below.

Light Age, Inc. Applicant: 500 Apgar Dr. Somerset, NJ 08873 Thomas C. Hauck, Manager of Quality and Process Technology

Date Prepared: December 24, 2003

Model:

Trade Name: Light Age Q-Clear™ Laser Hade Name: "Digit Aigh Nd:YAG Laser with Frequency Doubler

Product Code: GEX

Panel: 79

C.F.R. Section: 878.4810

Classification Panel: Gencral & Plastic Surgery

Classification:

Medical Device Class: Regulatory Class II

Laser Safety Class: Class IV Laser Product

Predicate Devices:

- Palomar Q-Y AG™ Nd:YAG Laser System (K023967) -
- Medlite™ Q-Switched Nd:YAG Laser (K022709 & K983054) -
- Mcdlite™ C3 Q-Switched Nd:YAG Laser (K011677) -
- Medlite™ C6 Q-Switched Nd:YAG Laser (K014234) -
- Spectra-VRM Q-Switched Nd:YAG Laser System (K000317) -

Description:

The Light Age Q-Clear™ Laser has a Nd: Y AG crystal rod as a lasing medium. Pulsed

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# LIGHT AGE, INC.

energy is emitted at 1064 nanometers in the near-infrared portion of the spectrum. With the optional frequency doubler installed, a 532nm beam is emitted. The 532nm emission is the optional frequency could mithe lascr is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety features in conformance with 21CFR Part 1040.

Intended Use:

The Light Age Q-Clear™ Laser is intended for the following uses:

- 1. For incision, excision, ablation, and vaporization of soft tissue for General Dermatology
- 2. The 1064nm wavelength is indicated for:
- Dark ink tattoo removal -
- Treatment of pigmented lesions (particularly Nevus of Ota) -
- Removal or lightening of hair -
- Skin resurfacing with or without adjuvant preparation :
- Treatment of common nevi --
- 3. The 532nm wavelength is indicated for:
- Removal of light ink (red, tan, purple and orange) tattoos ー
- Treatment of common nevi -
- Treatment of café-au-lait spots --
- Treatment of seborrheic kcratoses -
- Treatment of vascular lesions, including facial and leg veins, telangiectasias, : angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)

Safety and Effectiveness:

The Light Age Q-Clear™ Laser has the same wavelengths, the same spot size, the same Frie Light of operation, essentially the same fluence levels, and the same intended use as the predicate devices. The Light Age Q-Clear™ Laser does not raise new questions of safety or efficacy, and is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

FEB 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas C. Hauck Manager of Quality and Process Technology Light Age, Inc. 500 Apgar Drive Somerset, New Jersey 08873

Re: K033259 Trade/Device Name: Light Agc Q-Clear™ 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: January 20, 2004 Received: January 20, 2004

Dear Mr. Hauck:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave decemblied by marketed predicate devices marketed in interstate for use stated in the cherosure) to regary to regars and the Medical Device American son to any for at Free d. Fored. Four commerce province to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been reculssined in assess approval of a premarket approval application (PMA). and Costiere Act (Act) that do not requent sppto the general controls provisions of the Act. The You may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of the Procession, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aboro) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous of roants concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a baseas.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or ally recetal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set as the treat CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1950 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Thomas C. Hauck

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manceing your and equivalence of your device to a legally prematication. The PDF mailing of mailing of mailing of 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), plcase If you desire specific advice for Jour ac 1) 594-4659. Also, please note the regulation entitled, Colliact the Office of Compilance in the notification" (21CFR Part 807.97). You may obtain Misolanding by reference to promation on the Act from the Division of Small
other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-frec number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

h Mark N. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## LIGHT AGE, INC.

### Indications for Use

510(k) Number (if known): K033259

Device Name: Light Age Q-Clear™ Laser

Indications for Use:

The Light Age Q-Clear™ Laser is indicated for the following uses:

- 1. For incision, excision, ablation, and vaporization of soft tissue for General Dermatology
- 2. The 1064nm wavelength is indicated for:
- Dark ink tattoo removal ।
- Removal of pigmented Icsions (particularly Nevus of Ota) ..
- Removal or lightening of hair =
- Skin resurfacing with or without adjuvant preparation ー
- Treatment of common nevi --
- 3. The 532nm wavelength is indicated for:
- Removal of light ink (red, tan, purple and orange) tattoos -
- Treatment of common nevi |
- Treatment of café-au-lait spots -
- Treatment of seborrheic keratoses -
- Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | |
|------------------------|--|
| (21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <p>(Division Sign-Off)</p> |
|--|------------------------------------------------------------|
| | Division of General, Restorative, and Neurological Devices |

| (Posted November 13, 2003) | Page 1 of 1 |
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| 510(k) Number | K033259 |
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510(k)-Notification-Q-Clear-additional-info-2004-01-23b.doc