MEDLITE/ERBIUM LASER SYSTEM

K961748 · Continuum Biomedical, Inc. · GEX · Jul 26, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961748
• Device Name: MEDLITE/ERBIUM LASER SYSTEM
• Applicant: Continuum Biomedical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

Device Story

Medlite Erbium Laser System; 2.94μ wavelength laser; 10W average power (2J pulse energy at 5Hz). System comprises power supply, water cooling, and optical bench. Used by dermatologists for soft tissue surgery; incision, excision, ablation, vaporization, hemostasis. Clinical application includes skin resurfacing and dermabrasion.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Erbium laser; 2.94μ wavelength; 10W average power; 2J pulse energy; 5Hz repetition rate. System includes power supply, water cooling, and optical bench. Class 79-GEX surgical laser.

Indications for Use

Indicated for dermatological procedures requiring incision, excision, ablation, vaporization, and hemostasis of soft tissue, including skin resurfacing and dermabrasion.

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

• SEO Medical TriLase 2940 Erbium Laser System (K954013)

Submission Summary (Full Text)

{0}

510(k) PREMARKET NOTIFICATION
Medlite\Erbium Laser System
Continuum Biomedical, Inc.
Revised July 12, 1996
K961748

# 510(k) Summary

JUL 26 1996

| Submitter: | Continuum Biomedical, Inc.
2456 Armstrong Street
Livermore, CA 94550-7617
Phone: [phone]
Fax: [phone] |
| --- | --- |
| Contact: | Robert S. Anderson, Ph. D
President |
| Date Summary Prepared: | July 12, 1996 |
| Device Trade Name: | Medlite\Erbium Laser System |
| Common Name: | Dermatology laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | SEO Medical TriLase 2940 Erbium Laser System (K954013) |
| Device Description: | The Medlite\Erbium Laser is an erbium laser producing laser emissions at 2.94μ. The laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 10 watts. |
| Intended Use: | For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue. |
| Comparison: | The TriLase 2940 Erbium Laser has the ability to deliver laser energy at 2.94 microns, maximum power of 5 watts at repetition rates of up to 20 pulses per second. These characteristics are very similar to the Medlite\Erbium Laser System. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Medlite\Erbium Laser System is substantially equivalent to other existing surgical laser systems in commercial distribution for dermatology treatments such as skin resurfacing and dermabrasion. |
| Additional Information: | None requested at this time. |

c:\conb\k\mederb\510k.doc:13