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FDA 510(k)

PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1

K-Number: K911104 · 1991-06-11

ApplicantHgm Medical Laser Systems, Inc.
Decision Date1991-06-11
Product CodeFEX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 is the device name listed in this FDA 510(k) record. The listed applicant is Hgm Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 1991-06-11 under 510(k) number K911104. The device is classified under product code FEX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1?

PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 is a medical device that received FDA 510(k) clearance on 1991-06-11. The listed applicant is Hgm Medical Laser Systems, Inc.. The 510(k) number is K911104.

When did PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 receive FDA 510(k) clearance?

PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 received FDA 510(k) clearance on 1991-06-11, under 510(k) number K911104.

Who is the listed applicant for PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1?

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

What is the FDA product code for PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1?

The FDA product code for PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 is FEX.

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Other records listing Hgm Medical Laser Systems, 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.

K921300MODEL PC ARGON ION LASERK914484LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPEK913569COMPAC A, ELITE A, ELITE A PLUS, SURGICA AK912628AIR ARGON ION LASERS VARIOUS MODELSK910272HGM COMBINATION ND:YAG & SOLID STATE GREENK912438MODELS 5,8,20,20S ARGON ION LASERS

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Related Devices (Code: FEX)

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.

K771725BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.Xomed, 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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