Atlas FDA

HPG

7 FDA 510(k) clearances · Product code

86 daysmedian time to decision
114 days90th percentile
7clearances measured

FDA profile

Official device name
Aid, Vision, Electronic, Battery-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.5900
Medical specialty
Ophthalmic
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RecordFirmDate
PATHFINDER (K910601)Nurion Industries1991-05-14
LOW VISION ENHANCEMENT SYSTEM (LVES) (K910124)Triangle Investments1991-04-10
LASER CANE (K903558)Nurion Industries1990-09-27
POLARON (K902187)Nurion Industries1990-08-08
SENSORY 6 (K862338)Brytech, Inc.1986-09-03
ALES (K823385)Oms1983-03-09
F4912 NIGHT VISION AID (K761215)Itt Corp.1976-12-16

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