Atlas FDA

HOH

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Spectacle, Operating (Loupe), Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4770
Medical specialty
Ophthalmic
Flags
GMP exempt
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SURGITEL (K934494)General Scientific Corp.1994-01-25
LOW-POWER BINOCULAR LOUPE (K875124)Seiler Instrument & Mfg. Co., Inc.1988-02-19
EXETER OPERATING LOUPE (K810817)Exeter Instruments, Inc.1981-04-23

Track HOH automatically

Every clearance here is in the API, with alerts when new ones post.