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FDA 510(k)

SURGILASE YAG 100 FOR GYNECOLOGY USE

K-Number: K881499 · 1988-04-29

ApplicantSurgilase, Inc.
Decision Date1988-04-29
Product CodeLLO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SURGILASE YAG 100 FOR GYNECOLOGY USE is the device name listed in this FDA 510(k) record. The listed applicant is Surgilase, Inc.. It received FDA 510(k) clearance on 1988-04-29 under 510(k) number K881499. The device is classified under product code LLO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGILASE YAG 100 FOR GYNECOLOGY USE?

SURGILASE YAG 100 FOR GYNECOLOGY USE is a medical device that received FDA 510(k) clearance on 1988-04-29. The listed applicant is Surgilase, Inc.. The 510(k) number is K881499.

When did SURGILASE YAG 100 FOR GYNECOLOGY USE receive FDA 510(k) clearance?

SURGILASE YAG 100 FOR GYNECOLOGY USE received FDA 510(k) clearance on 1988-04-29, under 510(k) number K881499.

Who is the listed applicant for SURGILASE YAG 100 FOR GYNECOLOGY USE?

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 SURGILASE YAG 100 FOR GYNECOLOGY USE?

The FDA product code for SURGILASE YAG 100 FOR GYNECOLOGY USE is LLO.

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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: LLO)

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.

K884815SLT CLMD CONTACT LASERSurgical Laser Technologies, Inc.K880592LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USELaser Peripherals, LLCK880170MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSCooper Lasersonics, Inc.K874254ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONSMinnesota Laser Corp.K875104SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USELaserguideK871876MODEL 5050 SURGILASER FOR PULMONARY USELasermatic, 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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