LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX

K032991 · Light Age, Inc. · GEX · Sep 14, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K032991
• Device Name: LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
• Applicant: Light Age, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Light Age EpiCare™ Alexandrite Laser is indicated for permanent hair reduction, and the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Device Story

The Light Age EpiCare™ Alexandrite Laser utilizes an Alexandrite crystal rod to emit pulsed energy at 755 nm in the near-infrared spectrum. Energy is delivered to the target area via an optical fiber and handpiece, producing a circular beam on the skin. The device is used by clinicians in a medical setting for dermatological procedures. It incorporates safety interlocks to protect patients and operators. By delivering specific wavelengths of laser energy, the device targets hair follicles, vascular lesions, pigmented lesions, or skin tissue to achieve therapeutic outcomes. The clinician operates the device to treat the patient's skin, with the output affecting clinical decision-making regarding the management of hair growth and various skin conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and comparison to predicate devices.

Technological Characteristics

Alexandrite crystal rod laser; 755 nm wavelength; pulsed energy delivery via optical fiber and handpiece; Class IV laser product; safety interlocks included.

Indications for Use

Indicated for stable long-term or permanent hair reduction in all skin types (Fitzpatrick I-VI) including tanned skin, and for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

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

• Light Age™ EpiCare™ Alexandrite Laser (K983977)
• CandelaTM GentleLASE Alexandrite Laser (K024260, K024335 & K024371)
• Cynosure™ Apogee-TKS Alexandrite Laser (K992757)
• Cynosure™ Apogee-TKS II Alexandrite Laser (K031488)
• Sharplan™ Model 5000 Alexandrite Laser (K971874 & K973354)
• Lumenis™ LightSheer™ Pulsed Diode Laser (K003614)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 1 4 2004

## LIGHT AGE, INC.

#### 510(k) Summary of Safety and Effectiveness Light Age EpiCare™ Laser

In accordance with the Safe Medical Devices Act of 1990, 21CFR 807.92, the following is a summary of the safety and effectiveness information on which the substantial equivalence determination is based.

The safety and effectiveness of the Light Age EpiCare™ Laser derives from a I no barry and of substantial equivalence 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: Sept. 23, 2003

Description:

The Light Age EpiCare™ Alexandrite Laser has an Alexandrite crystal rod as a lasing medium. Pulsed energy is emitted at 755 nanometers in the near infrared portion of the spectrum. Energy from the laser is delivered to the target area via optical fiber with handpiece, which produces a circular beam on the skin. The EpiCare™ Alexandrite Laser is equipped with safety interlocks to protect patients and operators.

#### Intended Use:

The Light Age EpiCare™ Alexandrite Laser is indicated for permanent hair reduction, and the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Model:

Light Age EpiCare™ Alexandrite Laser Trade Name: Common Name: Pulsed Alexandrite Laser

Product Code: GEX

Panel: 79

C.F.R. Section: 878.4810

{1}------------------------------------------------

# LIGHT AGE, INC.

Classification Pariel: General & Plastic Surgery

Classification:

Medical Device Class: Regulatory Class II

Laser Safety Class: Class IV Laser Product

Predicate Devices:

- Light Age™ EpiCare™ Alexandrite Laser (K983977) -
- CandelaTM GentleLASE Alexandrite Laser (K024260, K024335 & K024371) -
- Cynosure™ Apogee-TKS Alexandrite Laser (K992757) -
- Cynosure™ Apogee-TKS II Alexandrite Laser (K031488) -
- Sharplan™ Model 5000 Alexandrite Laser (K971874 & K973354) -
- Lumenis™ LightSheer™ Pulsed Diode Laser (K003614) *

#### Description:

The Light Age EpiCare™ Alexandrite Laser has an Alexandrite crystal rod as a lasing The Light Age Loroare - Ancharden 755 nanometers in the near infrared portion of the modial. I ansoc onergy from the laser is delivered to the target area via optical fiber with Spectrum. Lifergy from the hass is a beam on the skin. The EpiCare™ Alexandrite Laser is equipped with safety interlocks to protect patients and operators.

#### Intended Use:

The Light Age EpiCare™ Alexandrite Laser is indicated for permanent hair reduction, and the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

#### Safety and Effectiveness:

The Light Age EpiCare™ Alexandrite Laser has essentially the same wavelength, the The Light Age Lpresar - principle of operation, essentially the same fluence levels, and Same sportsize, the bank the predicate devices. The Light Age EpiCare™ Alexandrite the same mention ass new questions of safety or efficacy, and is substantially equivalent to the predicate devices.

Advisory: This information was prepared for the sole purpose of compliance with the Advisory. This information was propession imply that the procedures described herein Salt Mcdroal Do roos Net equipment described without substantial risk of personal injury can oc portomied with the operator error or in procedures requiring a high degree of skill.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2004

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

Re: K032991

Trade/Device Name: Light Age EpiCare™ Alexandrite 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: July 28, 2004 Received: July 29, 2004

Dear Mr. Hauck:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your been mind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated of to the enactment date of the Medical Device Amendments, or to conninered prior to Prial 2011-17-11, in accordance with the provisions of the Federal Food, Drug, de nees mat have been recuire approval of a premarket approval application (PMA). and Cosmeter Fer (110) internet the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to been at 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 or ury 1 vith 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 forul in the qualis) 25500 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Mr. Thomas C. Hauck

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your to FDA finding of substantial equivalence of your device to a legally premaintent notification " 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 if you attire 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 other general micronational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

{4}------------------------------------------------

## LIGHT AGE, INC.

### Indications for Use

510(k) Number (if known): K032991

#### Device Name: Light Age EpiCare™ Alexandrite Laser

Indications For Use:

The Light Age EpiCare™ Alexandrite Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing after a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin.

It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

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)

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

Page 1_of 1

*(Posted November 13, 2003)* **510(k) Num**

510(k) Number kb32991