RD-1200H NORMAL MODE RUBY LASER SYSTEM

K955612 · Spectrum Medical Technologies, Inc. · GEX · Jul 9, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K955612
• Device Name: RD-1200H NORMAL MODE RUBY LASER SYSTEM
• Applicant: Spectrum Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectrum Epilaser® has several indications for use based on the selective absorption of natural chromophores, particularly melanin and tattoos. The Ruby laser wavelength of 694.3 nanometers and the pulse duration of the normal mode system are well absorbed by these pigments. Indications for use include the treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black).

Device Story

Normal mode ruby laser system; 694.3 nm wavelength; 10-40 J/cm² fluence; 200 μsec to 3 msec pulse duration; 5-12 mm spot size. Delivery via articulating arm and cooled contact handpiece. Targets melanin and tattoo pigments (blue/black) via selective photothermolysis. Used by clinicians in dermatology settings for lesion treatment and tattoo removal. Output is laser energy delivered to skin; clinical benefit is removal or reduction of pigmented lesions and tattoos.

Clinical Evidence

Evidence provided via in vitro, in vivo, and open literature clinical results demonstrating efficacy of normal mode ruby laser for pigmented lesion treatment and tattoo removal.

Technological Characteristics

Normal mode ruby laser; 694.3 nm wavelength; 10-40 J/cm² fluence; 200 μsec to 3 msec pulse duration; 5-12 mm spot size; articulating arm delivery; cooled contact handpiece.

Indications for Use

Indicated for treatment of benign epidermal pigmented lesions (lentigines, café au lait) and removal of blue and black 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

• pre-enactment normal mode ruby laser devices
• post-enactment devices with substantially equivalent mechanisms of action

Submission Summary (Full Text)

{0}

DATE: 7/1/96
TIME: 14:03:08
TO: 1-301-594-2.58

# K 955612

JUL 9 1996

## 510(k) Summary

RE: K955612, 510(k) Spectrum Epilaser® Normal Mode Ruby Laser

Date Prepared: July 3, 1996

Submitted by: Spectrum Medical Technologies, Inc.
(Wholly Owned Subsidiary of Palomar Medical Technologies, Inc., Beverly, MA)
45 Hartwell Avenue
Lexington, MA 02173
[phone]

Contact: Sanford Lane, President

Proprietary Name: Epilaser®

Common Name: Dermatology Laser System

Predicate Devices: The Epilaser® was compared to pre-enactment normal mode ruby laser devices of substantially equivalent physical characteristics and indications for use and to post enactment devices with substantially equivalent mechanisms of action and indications for use. Data from in vitro, in vivo and clinical results found in the open literature were also provided.

Device Description: The Epilaser® is a normal mode ruby laser operating at 694.3 nanometers with fluence levels from 10-40 J/cm², a pulse duration from 200 μsec to 3 msec and a spot size of 5-12 mm. The delivery system includes an articulating arm and cooled contact handpiece.

Intended Uses: The Spectrum Epilaser® has several indications for use based on the selective absorption of natural chromophores, particularly melanin and tattoos. The Ruby laser wavelength of 694.3 nanometers and the pulse duration of the normal mode system are well absorbed by these pigments. Indications for use include the treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black).

The Epilaser® was demonstrated to be substantially equivalent to the predicate devices on the basis of similar mechanisms of action and indications for use.