← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K955662

# CANDELA Q-SWITCHED ALEXANDRITE LASERS (K955662)

_Candela Laser Corp. · GEX · Jun 14, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K955662

## Device Facts

- **Applicant:** Candela Laser Corp.
- **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md)
- **Decision Date:** Jun 14, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **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.

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K955662](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K955662)

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