Atlas FDA

HLP

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Target, Fusion And Stereoscopic
Device class
Class I (low risk)
Regulation
21 CFR 886.1880
Medical specialty
Ophthalmic
Flags
GMP exempt
Adverse events (MAUDE)
1993: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VKG 1000, VIDEO KERATOMETER (K883471)Technitex, Inc.1988-11-08
THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. (K874250)Richmond Products, Inc.1988-01-11
WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT (K874251)Richmond Products, Inc.1988-01-11

Track HLP automatically

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