(239 days)
For use in general surgery for the incision, excision, ablation, vaporization, coagulation of soft tissue.
For use in dermatology for incision, excision, ablation and hemostatis of soft tissue.
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.
This 510(k) summary for the New Star Model 130 6-Watt Nd:YAG Laser System does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Instead, the summary focuses on demonstrating substantial equivalence to previously cleared devices. It states:
- 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."
Therefore, I cannot provide the requested information as it is not present in the provided text. This device was cleared based on its similarity to other legally marketed devices, rather than through a performance study against predefined acceptance criteria for a novel technology.
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K 962791
510(k) Summary
| Submitter. | New Star Lasers, Inc.11802 Kemper RoadAuburn, California 95603916-823-1434916-823-1446 fax |
|---|---|
| Contact: | David R. HenningsPresident |
| 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, laser79-GEX21 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 CoolantGebauer Fluro-Ethyl topical refrigerant(Pre-Amendment device) | |
| Device Description: | The New Star Model 130 laser is a compact, portable, self-containedsurgical laser system that produces a variable 1-6 watt beam of infraredradiation at 1320nm wavelength. The system emits a pulsed laserbeam which is delivered to the treatment site using a fiber optic deliverysystem. A visible light 0.5 mW HeNe laser beam at 632.8nm is used foraiming. |
| The system is comprised of a laser console, a fiber-optic deliverysystem, a foot switch and a removable electronic key interlock. Thesystem provides safety features that are designed to protect theoperator and patient from high voltage and laser emissions. | |
| ( |
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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,alming beam, beam delivery, energy monitor and fiber calibration for theNew Star Model 130 6-Watt Nd:YAG Laser System fall within the rangeof 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 substantiallyequivalent to other existing surgical laser systems in commercialdistribution for the incision, excision, ablation, vaporization andcoagulation of soft tissue. |
| Additional Information: | None requested at this time. |
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not assigned yet K 962791 510(k) Number (if known): New Star Model 130 6-watt Nd:YAG Laser System Device Name: For use in dermatology for incision, excision, ablation and Indications for Use: rol use in doming hemostatis of soft tissue.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.