MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE

K963340 · Continuum Biomedical, Inc. · GEX · May 12, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K963340
• Device Name: MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE
• Applicant: Continuum Biomedical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in dermatology for the removal of tattoos and the treatment of vascular and pigmented lesions.

Device Story

Dye Accessory Handpiece for Medlite Nd:YAG Laser System; consists of handpiece with optical cavity/focusing optics, plastic dye module, power meter, and safety goggles. Device modifies laser output wavelengths to increase efficiency for tattoo removal and treatment of vascular/pigmented lesions. Used in clinical dermatology settings by physicians. Output allows targeted laser energy delivery to skin lesions; enhances clinical efficacy for dermatological procedures.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Dye accessory handpiece; includes optical cavity, focusing optics, plastic dye module, and power meter. Modifies Nd:YAG laser output wavelengths. Class II surgical laser system (21 CFR 878.48).

Indications for Use

Indicated for patients requiring removal of tattoos or treatment of vascular and pigmented lesions in a dermatology setting.

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

• Medlite™ Nd:YAG Laser System (K955131)
• Medlite™ Nd:YAG Laser System (K952636)
• Medlite™ Nd:YAG Laser System (K940607)
• Medlite™ Nd:YAG Laser System (K940636)
• Medlite™ Nd:YAG Laser System (K922935)
• Medlite™ Nd:YAG Laser System (K922577)
• Medlite™ Nd:YAG Laser System (K915497)

Submission Summary (Full Text)

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510(K) PREMARKET NOTIFICATION
Medlite Nd:YAG Laser System
Continuum Biomedical, Inc.
August 23, 1996
MAY 12 1997
K 963340

# 510(k) Summary

| 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: | August 23, 1996 |
| Device Trade Name: | Medlite™ Nd:YAG Laser System: New Dye Accessory Handpiece |
| Common Name: | Dermatology laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Medlite™ Nd:YAG Laser System (K955131, K952636, K940607, K940636, K922935, K922577, K915497) |
| Device Description: | The new Dye Accessory Handpiece for the Medlite™ Nd:YAG Laser System is consists of four primary parts: the handpiece which contains a short optical cavity and focusing optics, the plastic dye module, the commercial power meter and appropriate laser safety goggles. |
| Intended Use: | For use in dermatology for the removal of tattoos and the treatment of vascular and pigmented lesions. |
| Comparison: | The new Dye Accessory Handpiece allows the Medlite™ Nd:YAG Laser System to deliver slightly altered wavelengths for increased efficiency in treating tattoos, vascular and pigmented lesions. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Medlite™ Nd:YAG Laser System is substantially equivalent to other existing surgical laser systems in commercial distribution for the treatment of tattoos, vascular and pigmented lesions. |
| Additional Information: | None requested at this time. |

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