AURALITE II— 510(k) K852403

Substantially Equivalent

Aura Lens Products

FDA 510(k) clearance K852403 for AURALITE II, Substantially Equivalent on 1985-08-20. Applicant: Aura Lens Products. Device class: 1.

Clearance details

Applicant: Aura Lens Products
Product code: Code HQG
Device class: Class 1
Regulation: 21 CFR 886.5844
Advisory panel: Ophthalmic
Date received: 1985-06-06
Decision date: 1985-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Cloud, MN, US

Download summary PDF View on FDA.gov ↗

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K882814 — NEOLENS PRESCRIPTION SPECTACLE LENS1988-07-29

More clearances from Aura Lens Products

K872506 — MELANITE I1987-07-27

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