CANDELA Q-SWITCHED ALEXANDRITE LASERS

K955662 · Candela Laser Corp. · GEX · Jun 14, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K955662
• Device Name: CANDELA Q-SWITCHED ALEXANDRITE LASERS
• Applicant: Candela Laser Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Candela Q-Switched Alexandrite Lasers intended for use in the treatment of pigmented lesions and tattoos.

Device Story

Q-switched alexandrite laser; emits 755 nm near-infrared pulsed energy; utilizes alexandrite rod crystal; electro-optical Q-switch controls pulse duration. Components: high voltage power supply/modulator, optical laser head, circulator system, microprocessor-based controller/display, optical fiber/handpiece delivery system. Used in dermatology/plastic surgery; operated by physician. Energy delivered to targeted skin area via handpiece. Safety interlocks included. User selects parameters via on-board control panel. Device treats pigmented lesions and tattoos via selective photothermolysis.

Clinical Evidence

Bench testing only; component and functional testing of completed laser system performed.

Technological Characteristics

Alexandrite rod crystal laser; 755 nm wavelength; electro-optical Q-switch; microprocessor-based controller; optical fiber delivery system; high voltage power supply; safety interlock systems.

Indications for Use

Indicated for patients requiring treatment of pigmented lesions and tattoos.

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

• Candela Q-Switched Alexandrite Laser (Models PLTL-1 and TL-1)
• Cynosure Photogenica T10 Tattoo Removal Laser

Submission Summary (Full Text)

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K 955662

510(k) SUMMARY

JUN 14 1996

## General Information

This premarket notification is for the Candela Q-Switched Alexandrite Lasers intended for use in the treatment of pigmented lesions and tattoos.

**Classification:** Class II (21 CFR 878.4810 Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology)

**Common Name:** Dermatology Laser, Q-Switched Alexandrite Laser

**Predicate Device:** Candela Q-Switched Alexandrite Laser (Models PLTL-1 and TL-1)
Cynosure Photogenica T10 Tattoo Removal Laser

## Description

The Candela Q-Switched Alexandrite Lasers utilize an alexandrite rod (crystal) which emits pulsed energy at 755 nm in the near-infrared region of the electromagnetic spectrum. An electro-optical Q-Switch is employed to control pulse duration. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Q-Switched Alexandrite Lasers are designed with five major components:

1) the high voltage power supply and modulator system;
2) the optical laser head;
3) the circulator system;
4) the microprocessor-based system controller and user display panel;
5) the optical delivery system.

The Candela Q-Switched Alexandrite Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an on-board control panel to regulate operation during treatment.

## Product Development Review

Design reviews conducted during development of this device verify the appropriateness of materials and design selection.

## Testing

Testing of the Candela Q-Switched Alexandrite Lasers consist of component testing and functional testing of the completed laser.

## Summary of Substantial Equivalence

On the basis of similarities in principles of operation, design, materials, source of energy, methods of assembly, and intended use, Candela has determined that its Q-Switched Alexandrite Lasers are substantially equivalent to the above referenced predicate devices.

No new questions of safety and efficacy are raised by the introduction of this device into commercial distribution.