← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K961006 # MEDLITE/755 ALEXANDRITE LASER SYSTEM (K961006) _Continuum Biomedical, Inc. · GEX · Sep 11, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K961006 ## Device Facts - **Applicant:** Continuum Biomedical, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Sep 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended 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. ## 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 - PhotoGenica T10 Laser ([K950684](/device/K950684.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\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: 510-606-3750 Fax: 510-371-1015 | | --- | --- | | 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. | c:\conbio\alex755\510k.doc:12 95 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K961006](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K961006) **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