KERATOLUX— 510(k) K854383

Substantially Equivalent

Carl Zeiss, Inc.

FDA 510(k) clearance K854383 for KERATOLUX, Substantially Equivalent on 1985-11-12. Applicant: Carl Zeiss, Inc.. Device class: 1.

Clearance details

Applicant: Carl Zeiss, Inc.
Product code: Code HPL
Device class: Class 1
Regulation: 21 CFR 886.1290
Advisory panel: Ophthalmic
Date received: 1985-10-30
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thornwood, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.