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FDA 510(k)

DERMATOLOGY HANDPIECE-OPHTH LASER

K-Number: K833274 · 1983-12-03

ApplicantSynemed, Inc.
Decision Date1983-12-03
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DERMATOLOGY HANDPIECE-OPHTH LASER is the device name listed in this FDA 510(k) record. The listed applicant is Synemed, Inc.. It received FDA 510(k) clearance on 1983-12-03 under 510(k) number K833274. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMATOLOGY HANDPIECE-OPHTH LASER?

DERMATOLOGY HANDPIECE-OPHTH LASER is a medical device that received FDA 510(k) clearance on 1983-12-03. The listed applicant is Synemed, Inc.. The 510(k) number is K833274.

When did DERMATOLOGY HANDPIECE-OPHTH LASER receive FDA 510(k) clearance?

DERMATOLOGY HANDPIECE-OPHTH LASER received FDA 510(k) clearance on 1983-12-03, under 510(k) number K833274.

Who is the listed applicant for DERMATOLOGY HANDPIECE-OPHTH LASER?

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

What is the FDA product code for DERMATOLOGY HANDPIECE-OPHTH LASER?

The FDA product code for DERMATOLOGY HANDPIECE-OPHTH LASER is HQF.

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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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