LASERSAFE EYE SHIELDS— 510(k) K852404

Substantially Equivalent

Lasersafe, Inc.

FDA 510(k) clearance K852404 for LASERSAFE EYE SHIELDS, Substantially Equivalent on 1985-10-04. Applicant: Lasersafe, Inc.. Device class: 1.

Clearance details

Applicant: Lasersafe, Inc.
Product code: Code HOY
Device class: Class 1
Regulation: 21 CFR 886.4750
Advisory panel: Ophthalmic
Date received: 1985-06-06
Decision date: 1985-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Lasersafe, Inc.

K854266 — STERILE LASER RESISTANT SURGICAL FIELD DRAPE1986-03-27
K852405 — LASERSAFE PERSONNEL AND PATIENT SHIELDS1985-10-01

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