MEDLITE/755 ALEXANDRITE LASER SYSTEM

K961006 · Continuum Biomedical, Inc. · GEX · Sep 11, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961006
• Device Name: MEDLITE/755 ALEXANDRITE LASER SYSTEM
• Applicant: Continuum Biomedical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Treatment of pigmented lesions.

Device Story

Flashlamp-excited Q-switched solid-state laser; emits 755nm wavelength; used for pigmented lesion removal. Operated by clinicians in dermatological settings. Device delivers pulsed laser energy to target chromophores in skin. Output parameters (spot size, energy, exposure duration) comparable to existing surgical laser systems. Clinical benefit derived from targeted laser-tissue interaction for lesion clearance.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Flashlamp-excited Q-switched solid-state laser; 755nm ±25nm wavelength; pulsed mode operation. Standalone surgical laser system.

Indications for Use

Indicated for the treatment of pigmented lesions in patients requiring laser-based dermatological therapy.

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

• PhotoGenica T10 Laser (K950684)

Submission Summary (Full Text)

{0}

510(k) PREMARKET NOTIFICATION
Medlite\755™ Alexandrite Laser System for Pigmented Lesion Removal
Continuum Biomedical, Inc.
March 11, 1996
SEP 11 1996
K96/006

# 510(k) Summary

| Submitter: | Continuum Biomedical, Inc.
547 Rhea Way
Livermore, CA 94550
Phone: [phone]
Fax: [phone] |
| --- | --- |
| Contact: | Robert S. Anderson, Ph. D.
President |
| Date Summary Prepared: | March 11, 1996 |
| Device Trade Name: | Medlite\755™ Alexandrite Laser System |
| Common Name: | Dermatology laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | PhotoGenicaT^{10} Laser (Cynosure) K950684 |
| Device Description: | The Medlite\755 Alexandrite Laser is a flashlamp excited Q-switched solid state laser producing a broadband wavelength of 755 ±25nm. Medlite\755™ Alexandrite Laser System is currently marketed under K935631, SE date 08/23/94, for tattoo removal. |
| Intended Use: | Treatment of pigmented lesions. |
| Comparison: | Cynosure's PhotoGenica T^{10} Laser emits light at 752nm in a flashlamp-excited pulsed mode. Indications for use, target, chromophore, delivery system, spot size, mode of operation, exposure duration, average laser power, energy to lesion aiming beam, laser wavelength, etc. for the Medlite\755 Alexandrite Laser System are all within the parameters currently in use by other systems which have been previously found to be substantially equivalent. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Medlite\755 Alexandrite Laser System is substantially equivalent to other existing surgical laser systems in commercial distribution for the treatment of pigmented lesions. |
| Additional Information: | None requested at this time. |

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