← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K963340 # MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE (K963340) _Continuum Biomedical, Inc. · GEX · May 12, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K963340 ## Device Facts - **Applicant:** Continuum Biomedical, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** May 12, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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). ## Regulatory 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](/device/K955131.md)) - Medlite™ Nd:YAG Laser System ([K952636](/device/K952636.md)) - Medlite™ Nd:YAG Laser System ([K940607](/device/K940607.md)) - Medlite™ Nd:YAG Laser System ([K940636](/device/K940636.md)) - Medlite™ Nd:YAG Laser System ([K922935](/device/K922935.md)) - Medlite™ Nd:YAG Laser System ([K922577](/device/K922577.md)) - Medlite™ Nd:YAG Laser System ([K915497](/device/K915497.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: 510-606-3750 Fax: 510-371-1015 | | --- | --- | | 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. | c:\conbiol\medlite\510kcolor.doc:13 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K963340](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K963340) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com