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FDA 510(k)

ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY

K-Number: K875039 · 1988-04-13

ApplicantSurgilase, Inc.
Decision Date1988-04-13
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Surgilase, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K875039. The device is classified under product code LNK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY?

ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Surgilase, Inc.. The 510(k) number is K875039.

When did ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY receive FDA 510(k) clearance?

ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY received FDA 510(k) clearance on 1988-04-13, under 510(k) number K875039.

Who is the listed applicant for ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY?

The FDA 510(k) record lists Surgilase, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY?

The FDA product code for ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY is LNK.

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Other records listing Surgilase, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932421SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASEK924664SURGILASE FIBERLASE CO2 LASER WAVEGUIDEK905006SURGILASE SL 150 SURGICAL LASER SYSTEMK904203SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEMK902211SURGILASE YAG 100 SURGICAL LASER SYSTEMK900570SURGILASE YAG 100 IN ORTHOPEDIC SURGERY

View all 19 devices →

Related Devices (Code: LNK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K925395TECHNOMED PULSOLITH 4000 LASER SYSTEMTeknomed, Inc.K901723MDL-2000 LASERTRIPTERCandela Laser Corp.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.Minnesota Laser Corp.K880256MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USESharplan Lasers, Inc.K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESharplan Lasers, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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