KROM-X LENS SYSTEM— 510(k) K865103

Substantially Equivalent

Neo Optics, Inc.

FDA 510(k) clearance K865103 for KROM-X LENS SYSTEM, Substantially Equivalent on 1987-01-20. Applicant: Neo Optics, Inc.. Device class: 1.

Clearance details

Applicant: Neo Optics, Inc.
Product code: Code HQG
Device class: Class 1
Regulation: 21 CFR 886.5844
Advisory panel: Ophthalmic
Date received: 1986-12-30
Decision date: 1987-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQG

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K900091 — MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR1990-04-04
K884360 — SEIKO P-6 PROGRESSIVE SPECTACLE LENSES1988-11-15
K882814 — NEOLENS PRESCRIPTION SPECTACLE LENS1988-07-29

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