← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K962791 # NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM (K962791) _New Star Lasers, Inc. · GEX · Mar 13, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962791 ## Device Facts - **Applicant:** New Star Lasers, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Mar 13, 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 general surgery for the incision, excision, ablation, vaporization, coagulation of soft tissue. ## Device Story Compact, portable, self-contained surgical laser system; produces variable 1-6 watt infrared radiation beam at 1320nm wavelength. System emits pulsed laser beam delivered via fiber optic delivery system; includes 0.5 mW HeNe aiming beam (632.8nm). Components include laser console, fiber-optic delivery system, foot switch, and removable electronic key interlock. Used by clinicians in surgical/dermatological settings for soft tissue incision, excision, ablation, vaporization, and coagulation. Safety features protect operator/patient from high voltage and laser emissions. ## Clinical Evidence No clinical performance data provided. No nonclinical performance data provided. ## Technological Characteristics Nd:YAG laser system; 1320nm wavelength; 1-6 watt output; pulsed beam. Includes fiber optic delivery system, HeNe aiming beam (632.8nm), foot switch, and electronic key interlock. Compact, portable form factor. ## 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 - New Star Model 600 Holmium Laser System ([K952489](/device/K952489.md)) - Optica 60 Nd:YAG Laser System ([K912703](/device/K912703.md)) - Opmilas 144 Nd:YAG Laser System ([K932376](/device/K932376.md), [K933322](/device/K933322.md)) - ADL 400 ([K920106](/device/K920106.md)) ## Reference Devices - Gebauer Fluro-Ethyl topical refrigerant ## 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 New Star Model 130 6-watt Nd:YAG Laser System New Star Lasers, Inc. July 16, 1996 K 962791 # 510(k) Summary Submitter: New Star Lasers, Inc. 11802 Kemper Road Auburn, California 95603 916-823-1434 916-823-1446 fax Contact: David R. Hennings President Date Summary Prepared: July 16, 1996 Device Trade Name: New Star Model 130 6-Watt Nd:YAG Laser System Common Name: Surgical laser system Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR 878.48 Equivalent Devices: Laser: New Star Model 600 Holmium Laser System, New Star Lasers, Inc. (K952489) Optica 60 Nd:YAG Laser System, XINTEC Corp. (K912703) Opmilas 144 Nd:YAG Laser System, Carl Zeiss, Inc. (K932376, K933322) ADL 400, Sunrise Technologies, Inc. (K920106) Optional Coolant Gebauer Fluro-Ethyl topical refrigerant (Pre-Amendment device) Device Description: The New Star Model 130 laser is a compact, portable, self-contained surgical laser system that produces a variable 1-6 watt beam of infrared radiation at 1320nm wavelength. The system emits a pulsed laser beam which is delivered to the treatment site using a fiber optic delivery system. A visible light 0.5 mW HeNe laser beam at 632.8nm is used for aiming. The system is comprised of a laser console, a fiber-optic delivery system, a foot switch and a removable electronic key interlock. The system provides safety features that are designed to protect the operator and patient from high voltage and laser emissions. c:newstar510k.doc:16 nss {1} 510(k) PREMARKET NOTIFICATION New Star Model 130 6-watt Nd:YAG Laser System New Star Lasers, Inc. July 16, 1996 # 510(k) Summary (cont'd) Intended Use: For use in general surgery for the incision, excision, ablation, vaporization, coagulation of soft tissue. Comparison: Pulse duration, pulse repetition rate, power, energy per pulse, exposure, aiming beam, beam delivery, energy monitor and fiber calibration for the New Star Model 130 6-Watt Nd:YAG Laser System fall within the range of values available on the referenced equivalent systems. Nonclinical Performance Data: none Clinical Performance Data: none Conclusion: The New Star Model 130 6-Watt Nd:YAG Laser System is substantially equivalent to other existing surgical laser systems in commercial distribution for the incision, excision, ablation, vaporization and coagulation of soft tissue. Additional Information: None requested at this time. c:newstar/510k.doc:17 hSh 121 {2} 510(k) PREMARKET NOTIFICATION New Star Model 130 6-watt Nd:YAG Laser System New Star Lasers, Inc. July 16, 1996 Page 1 of 1 510(k) Number (if known): not assigned yet K 962791 Device Name: New Star Model 130 6-watt Nd:YAG Laser System Indications for Use: For use in dermatology for incision, excision, ablation and vaporization with hemostatis of soft tissue. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ___________ OR Over-the-Counter Use ___________ (Per 21 CFR 801.109) (Optional Format 1-2-96) c:\newstar\510k.doc:9 NS --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962791](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962791) **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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