SHARPLAN LASERS, INC. RUBY LASER SYSTEM

K961279 · Sharplan Lasers, Inc. · GEX · Jun 18, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961279
• Device Name: SHARPLAN LASERS, INC. RUBY LASER SYSTEM
• Applicant: Sharplan Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sharplan Lasers, Inc. Ruby Laser System is substantially equivalent to the following devices: the Spectrum RD-1200 Ruby Laser and Derma-Lase DLR Ruby Laser, (K910422 and K924647, respectively). It is intended for use in dermatology for photothermolysis, for the specific indications {in adults (18 years or older)} to remove blue-black tattoos, or to remove or lighten benign epidermal pigmented lesions.

Device Story

Surgical ruby laser system; delivers pulsed 694.3 nm laser energy via articulated arm beam delivery system. Physician-operated in clinical setting; uses foot switch for activation; includes 633 nm HeNe aiming beam for visualization. Device performs photothermolysis for dermatological applications. Output allows physician to target specific pigmented lesions or tattoo pigments; clinical decision-making based on visual assessment of skin condition. Benefits include non-invasive removal or lightening of tattoos and benign epidermal lesions.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Ruby laser source; 694.3 nm wavelength; 633 nm HeNe aiming beam; articulated arm beam delivery; 5-8mm spot size; foot switch activation.

Indications for Use

Indicated for adults (18+) for removal of blue-black tattoos or removal/lightening of benign epidermal pigmented lesions.

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

• Spectrum RD-1200 Ruby Laser (K910422)
• Derma-Lase DLR Ruby Laser (K924647)

Submission Summary (Full Text)

{0}

JUN 18 1996
K 961279

# 510(k) Summary of Safety and Effectiveness
## Sharplan Lasers, Inc. Ruby Laser System

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Sharplan Lasers, Inc. Ruby Laser System is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Spectrum RD-1200 Ruby Laser and the Derma-Lase DLR Ruby Laser.

## 1. Firm:

Sharplan Lasers, Inc.
1 Pearl Court
Allendale, NJ 07401
April 1, 1996
George J. Hattub, Director of Regulatory Affairs
1-800-394-2000, ext. 531

## 2. Model:

Sharplan Lasers, Inc. Ruby Laser System

## 3. Predicate Devices:

The Spectrum RD-1200 Ruby Laser and the Derma-Lase DLR Ruby Laser

## 4. Description:

The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed laser energy of a 694.3 nm wavelength through an articulated arm beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.

## 5. Intended Use:

The Sharplan Lasers, Inc. Ruby Laser System is substantially equivalent to the following devices: the Spectrum RD-1200 Ruby Laser and Derma-Lase DLR Ruby Laser, (K910422 and K924647, respectively). It is intended for use in dermatology for photothermolysis, for the specific indications {in adults (18 years or older)} to remove blue-black tattoos, or to remove or lighten benign epidermal pigmented lesions.

No new indications were sought in this premarket notification and no clinical data was presented.

REVISED JUNE 7, 1996

{1}

510(k) Summary of Safety and Effectiveness (continued)
Sharplan Lasers, Inc. Ruby Laser System

## 6. Technological Characteristics

From a clinical performance perspective, the aforementioned devices produce a similar therapeutic output in terms of laser wavelength and spot size (5-8mm). Regarding the technological characteristics, while are not identical, physical testing of the device has demonstrated that it is similar both in function and performance to its predicate devices. Sharplan Lasers, Inc. believes that none of the differences of the device raise any issues pertaining to its safety or efficacy.

**Advisory:** This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.

REVISED JUNE 7, 1996