Product code HLX— Ophthalmic
5010 VISUSTIM
- Classification name
- Photostimulator, Ac-Powered
- Device class
- Class 2
- Regulation
- 21 CFR 886.1630
- Advisory panel
- Ophthalmic
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code HLX
FDA has cleared devices under product code HLX between 1979 and 2001, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2001
- 1999
- 1993
- 1992
- 1991
- 1988
- 1985
- 1984
- 1983
- 1982
- 1981
- 1979
Top applicants under product code HLX
Recent clearances under product code HLX
- K003442 — MODIFICATION TO EDI VERIS SYSTEM
- K983983 — EDI VERIS SYSTEM
- K925741 — CLARUS ENDOSCOPIC HOOK KNIFE
- K914393 — RETINA TESTER
- K914163 — SCOPTOPIC SENSITIVITY TEST-1[SST-1]
- K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR
- K853812 — PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)
- K833446 — DOWNING SPECTRAL ILLUMINATOR
- K832762 — MILLER/NADLER GLARE TESTER
- K831231 — LED GOGGLES
- K830770 — CONTRAST SENSITIVITY EQUIPMENT
- K822915 — 5031 BRIGHT FLASH STIMULATOR
- K822919 — 5010 VISUSTIM
- K822922 — 5011 GANZFELD STIMULATOR
- K822923 — 5012 PARABOLIC STIMULATOR
- K812331 — VTS-1000 VISUAL TESTING SYSTEM
- K810699 — PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM
- K790637 — COMPUTERIZED ELECTRO-OCULOGRAPH
Data sourced from openFDA. This site is unofficial and independent of the FDA.