K823385 is the FDA 510(k) clearance record for ALES, a class I device, cleared for Oms on 1983-03-09 under FDA product code HPG (Aid, Vision, Electronic, Battery-Powered). FDA records list one 510(k) clearance for Oms. As of 2026-09-10 , FDA records show no recalls naming K823385.
Clearance record Decision date 1983-03-09 Received 1982-11-15 (114 days to decision) Product code HPG Aid, Vision, Electronic, Battery-PoweredRegulation 21 CFR 886.5900 Device class Class I Review panel Ophthalmic Applicant Oms 803 N. Front St. Suite 3, Mchenry IL Third party review No
Clearances, product code HPG Trailing 12 months FDA records hold no clearances under product code HPG in the trailing twelve months.
FDA records show no clearances under product code HPG in the twelve months to October 2026. Show the numbers FIRST ARTICLE / WEEKLY
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Product code HPG
FDA records show no recalls under product code HPG.
MDM coverage of this record lists here, newest first.
About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
