510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K828674Substantially Equivalent

Dermalight Blue-Point

Dr. K. Honle GmbH, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K828674 is the FDA 510(k) clearance record for DERMALIGHT BLUE-POINT, cleared for Dr. K. Honle GmbH on . FDA records list 3 510(k) clearances for Dr. K. Honle GmbH. As of , FDA records show no recalls naming K828674.

Clearance record

Decision date
Received
(48 days to decision)
Review panel
Unknown
Applicant
Dr. K. Honle GmbH 4221 Richmond Rd., NW, Walker MI
Third party review
No