NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM

K962791 · New Star Lasers, Inc. · GEX · Mar 13, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K962791
• Device Name: NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• 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.

Indications for Use

Indicated for use in dermatology for incision, excision, ablation and vaporization with hemostatis of soft tissue.

Regulatory Classification

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)
• Optica 60 Nd:YAG Laser System (K912703)
• Opmilas 144 Nd:YAG Laser System (K932376, K933322)
• ADL 400 (K920106)

Reference Devices

• Gebauer Fluro-Ethyl topical refrigerant

Submission Summary (Full Text)

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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.

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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.

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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)

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