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
Indications for 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: 510-606-3750
Fax: 510-371-1015 |
| --- | --- |
| 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. |
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