FDA 510(k)

DERMALIGHT SPOT

K-Number: K828676 · 1983-01-17

Decision Date1983-01-17

Product Code

DecisionSubstantially Equivalent

Device Summary

DERMALIGHT SPOT is the device name listed in this FDA 510(k) record. The listed applicant is Dr. K. Honle GmbH. It received FDA 510(k) clearance on 1983-01-17 under 510(k) number K828676. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMALIGHT SPOT?

DERMALIGHT SPOT is a medical device that received FDA 510(k) clearance on 1983-01-17. The listed applicant is Dr. K. Honle GmbH. The 510(k) number is K828676.

When did DERMALIGHT SPOT receive FDA 510(k) clearance?

DERMALIGHT SPOT received FDA 510(k) clearance on 1983-01-17, under 510(k) number K828676.

Who is the listed applicant for DERMALIGHT SPOT?

The FDA 510(k) record lists Dr. K. Honle GmbH as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dr. K. Honle GmbH as applicant

K828674DERMALIGHT BLUE-POINT K828675DERMALIGHT UVASTAR 400

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.