ALES— 510(k) K823385

Substantially Equivalent

Oms

FDA 510(k) clearance K823385 for ALES, Substantially Equivalent on 1983-03-09. Applicant: Oms. Device class: 1.

Clearance details

Applicant: Oms
Product code: Code HPG
Device class: Class 1
Regulation: 21 CFR 886.5900
Advisory panel: Ophthalmic
Date received: 1982-11-15
Decision date: 1983-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HPG

K910601 — PATHFINDER1991-05-14
K910124 — LOW VISION ENHANCEMENT SYSTEM (LVES)1991-04-10
K903558 — LASER CANE1990-09-27
K902187 — POLARON1990-08-08
K862338 — SENSORY 61986-09-03

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