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FDA 510(k)

SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80

K-Number: K884092 · 1988-10-13

ApplicantSurgilase, Inc.
Decision Date1988-10-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 is the device name listed in this FDA 510(k) record. The listed applicant is Surgilase, Inc.. It received FDA 510(k) clearance on 1988-10-13 under 510(k) number K884092. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80?

SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 is a medical device that received FDA 510(k) clearance on 1988-10-13. The listed applicant is Surgilase, Inc.. The 510(k) number is K884092.

When did SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 receive FDA 510(k) clearance?

SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 received FDA 510(k) clearance on 1988-10-13, under 510(k) number K884092.

Who is the listed applicant for SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80?

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 CO2 SURGICAL LASER SYSTEM MODEL SL80?

The FDA product code for SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 is GEX. This falls under the Gastroenterology category.

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Other records listing Surgilase, Inc. as applicant

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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

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Related Devices (Code: GEX)

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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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