NUVO-LASE 660 LASER SYSTEM

K970667 · American Laser Medical · GEX · May 13, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970667
• Device Name: NUVO-LASE 660 LASER SYSTEM
• Applicant: American Laser Medical
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nuvo-Lase 660 Laser System is intended for use in the treatment of selected vascular and pigmented lesions of the skin. Laser light is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue.

Device Story

Nuvo-Lase 660 is a continuous wave (CW) frequency-doubled Nd:YAG laser system emitting at 532 nm; 3 Watts output. Device used by physicians in clinical settings for photocoagulation of skin lesions. Operator activates laser via footswitch; exposure times range from 0.02s to continuous. System includes focusing handpiece with interchangeable guide tips and optional Hexascan Mark II. Laser energy targets specific chromophores in tissue to treat vascular and pigmented lesions. Benefits include precise tissue photocoagulation for dermatological conditions.

Clinical Evidence

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

Technological Characteristics

CW frequency-doubled Nd:YAG laser; 532 nm wavelength; 3W output. Air-cooled by fans. Dimensions: 10x14x5 inches; weight: 20 lbs. Power: 115 VAC. Accessories: focusing handpiece, interchangeable guide tips, Hexascan Mark II. Non-computer controlled.

Indications for Use

Indicated for treatment of vascular lesions (capillary hemangioma/port wine, strawberry hemangioma, telangiectasia, rosacea) and pigmented lesions (freckles, age spots, cafe-au-lait, lentigo) of the skin.

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

• Laserscope Aura
• Lihtan 532

Submission Summary (Full Text)

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Nuvo-Lase 660 Laser System
American Laser Medical
February 21, 1997
K 970667
MAY 13 1997

# Summary of Safety and Effectiveness Information

## Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

## Company Name/Contact:

**Company:** American Laser Medical
1832 South 3850 West
Salt Lake City, UT 84104
[phone], FAX [phone]

**Contact:** Mr. Daniel Hoefer
Regulatory Affairs
American Laser Medical
1832 South 3850 West
Salt Lake City, UT 84104
[phone], FAX [phone]

## Name of Device:

**Trade Name:** Nuvo-Lase 660 Laser System

**Common Name:** Dermatology Laser

## Classification:

Powered surgical laser instruments are assigned the unique device classification code 79GEX. The published physical description of this device is found in 21 CFR, § 878.4810 (a) (2). This device classification section specifically describes argon laser systems. The American Laser Medical device is a CW 532 nm frequency doubled Nd:YAG laser system. However, for the purposes of this submission, American Laser Medical maintains that there is no substantial difference in CW frequency doubled Nd:YAG and argon laser systems. Presently, these lasers are considered Class II medical devices.

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Nuvo-Lase 660 Laser System
American Laser Medical
February 21, 1997

## Description of Device:

The Nuvo-Lase 660 Laser System submission covers all of the internal parts, subassemblies and components as well as the completed device. The Nuvo-Lase Model 660 is a continuous wave frequency-doubled Nd:YAG laser system with output at 532 nm.

Treatment beam output for the Nuvo-Lase 660 laser 3 Watts continuous wave at 532 nm. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Nuvo-Lase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous.

Laser activation occurs by footswitch. Overall weight of the system is 20 lbs. (9 kg). The Nuvo-Lase 660 Laser System has dimensions of 10 X 14 X 5 inches (25 X 36 X 13 cm).

The electrical power requirement is 115 VAC 15 amp single phase. The system is air-cooled by fans.

Accessories available for use with the Nuvo-Lase 660 Laser include a focusing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Nuvo-Lase 660 Laser System is not a computer controlled device.

## Intended Use:

The Nuvo-Lase 660 Laser System is intended for use in the treatment of selected vascular and pigmented lesions of the skin. Laser light is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue.

## Indications for Use:

The Nuvo-Lase 660 Laser is intended for use in the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are:

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Nuvo-Lase 660 Laser System
American Laser Medical
February 21, 1997

# Nuvo-Lase Model 660 Laser System
For vascular lesions: (Green - 532 nm)

1. Capillary Hemangioma (port wine hemangioma)
2. Strawberry hemangioma
3. Telangiectasia
4. Rosacea

For pigmented lesions: (Green - 532 nm).

1. Freckles
2. Age Spots
3. Cafe-au-lait
4. Lentigo

## Comparison of Device Characteristics:

### For vascular lesions:

The Nuvo-Lase 660 Laser System is substantially equivalent to the Laserscope Aura and the Lihtan 532 already in commercial distribution. The materials, design, intended use, method of manufacture, warnings, cautions, precautions and treatment parameters are substantially the same.

### For pigmented lesions:

The Nuvo-Lase 660 Laser System is substantially equivalent to the Laserscope Aura and the Lihtan 532, already in commercial distribution. The materials, design, intended use, method of manufacture, warnings, cautions, precautions and treatment parameters are substantially the same.

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