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FDA 510(k)

OPTHALAS PHOTOCOAGULATOR

K-Number: K828585 · 1983-01-03

ApplicantSynemed, Inc.
Decision Date1983-01-03
Product Code
DecisionSubstantially Equivalent

Device Summary

OPTHALAS PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Synemed, Inc.. It received FDA 510(k) clearance on 1983-01-03 under 510(k) number K828585. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTHALAS PHOTOCOAGULATOR?

OPTHALAS PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1983-01-03. The listed applicant is Synemed, Inc.. The 510(k) number is K828585.

When did OPTHALAS PHOTOCOAGULATOR receive FDA 510(k) clearance?

OPTHALAS PHOTOCOAGULATOR received FDA 510(k) clearance on 1983-01-03, under 510(k) number K828585.

Who is the listed applicant for OPTHALAS PHOTOCOAGULATOR?

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

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Other records listing Synemed, 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.

K954037FIELD TRENDK852936THE FIELDMASTER MODEL 275K833274DERMATOLOGY HANDPIECE-OPHTH LASERK831085SYNEVAC VACUUM SOURCE UNITK822853MODEL 200 SQUIDK813282SYNEVAC VACUUM CURETTAGE SYSTEMS

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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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