← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K961748 # MEDLITE/ERBIUM LASER SYSTEM (K961748) _Continuum Biomedical, Inc. · GEX · Jul 26, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K961748 ## Device Facts - **Applicant:** Continuum Biomedical, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Jul 26, 1996 - **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 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. ## 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 - SEO Medical TriLase 2940 Erbium Laser System ([K954013](/device/K954013.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\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. | c:\conb\k\mederb\510k.doc:13 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K961748](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K961748) **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. 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