Atlas FDA

HLX

18 FDA 510(k) clearances · Product code

88 daysmedian time to decision
179 days90th percentile
18clearances measured

FDA profile

Official device name
Photostimulator, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1630
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Sort:Newest firstOldest first

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

RecordFirmDate
MODIFICATION TO EDI VERIS SYSTEM (K003442)Electro-Diagnostic Imaging, Inc.2001-05-04
EDI VERIS SYSTEM (K983983)Electro-Diagnostic Imaging, Inc.1999-02-03
CLARUS ENDOSCOPIC HOOK KNIFE (K925741)Clarus Medical Systems, Inc.1993-08-24
RETINA TESTER (K914393)Retina Tester1992-03-02
SCOPTOPIC SENSITIVITY TEST-1[SST-1] (K914163)Lkc Technologies, Inc.1991-10-25
IRAS EDS INTERFEROMETRIC STIMULATOR (K873990)Randwal Instrument Co., Inc.1988-02-05
PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (K853812)Biosan Laboratories, Inc.1985-11-01
DOWNING SPECTRAL ILLUMINATOR (K833446)Vision Health Technology1984-03-12
MILLER/NADLER GLARE TESTER (K832762)Titmus Optical, Inc.1983-09-29
LED GOGGLES (K831231)Cadwell Laboratories, Inc.1983-05-16
CONTRAST SENSITIVITY EQUIPMENT (K830770)Cadwell Laboratories, Inc.1983-04-28
5012 PARABOLIC STIMULATOR (K822923)Life-Tech Intl., Inc.1982-12-28
5011 GANZFELD STIMULATOR (K822922)Life-Tech Intl., Inc.1982-12-28
5031 BRIGHT FLASH STIMULATOR (K822915)Life-Tech Intl., Inc.1982-12-28
5010 VISUSTIM (K822919)Life-Tech Intl., Inc.1982-12-28
VTS-1000 VISUAL TESTING SYSTEM (K812331)Nicolet Biomedical Instruments1981-11-16
PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM (K810699)Visidyne Corp.1981-06-09
COMPUTERIZED ELECTRO-OCULOGRAPH (K790637)Potomac Medical System1979-08-28

Track HLX automatically

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