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FDA 510(k)

SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE

K-Number: K880071 · 1988-03-22

ApplicantLaserguide
Decision Date1988-03-22
Product CodeFCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE is the device name listed in this FDA 510(k) record. The listed applicant is Laserguide. It received FDA 510(k) clearance on 1988-03-22 under 510(k) number K880071. The device is classified under product code FCS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE?

SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE is a medical device that received FDA 510(k) clearance on 1988-03-22. The listed applicant is Laserguide. The 510(k) number is K880071.

When did SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE receive FDA 510(k) clearance?

SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE received FDA 510(k) clearance on 1988-03-22, under 510(k) number K880071.

Who is the listed applicant for SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE?

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

What is the FDA product code for SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE?

The FDA product code for SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE is FCS.

Related Clinical Trials

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.

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Other records listing Laserguide 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.

K875104SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USEK873892SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USEK873571LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBEK873664LIGHT-SPOT FIBEROPTIC LASER HANDPIECE

Related Devices (Code: FCS)

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.

K061548STRYKER URETERAL ILLUMINATION SYSTEM IVStryker Corp.K982542STRYKER URETERAL ILLUMINATOR SYSTEM IIIStryker EndoscopyK943801URIGLOW TRANSILLUMINATING URETERIC STENT MODELRocket of London, Ltd.K945088GABRIEL URETERAL ILLUMINATOR SYSTEM IIGabriel Medical, Inc.K941506URETERAL ILLUMINATORApple Medical Corp.K940019GABRIEL URETERAL ILLUMINATOR SYSTEMGabriel Medical, 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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