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
Indications for 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.
