LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE— 510(k) K914484

Name: FDA 510(k) clearance K914484
Creator: U.S. Food and Drug Administration
Published: 1992-01-06

Substantially Equivalent

Hgm Medical Laser Systems, Inc.

FDA 510(k) clearance K914484 for LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE, Substantially Equivalent on 1992-01-06. Applicant: Hgm Medical Laser Systems, Inc.. Device class: 2.

Clearance details

Applicant: Hgm Medical Laser Systems, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1991-10-08
Decision date: 1992-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLI

view all

K153080 — RTVue XR OCT Avanti with AngioVue Software2016-02-11
K150722 — EnFocus 2300, EnFocus 44002015-12-02
K142953 — OCT-Camera2015-03-04
K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE2014-09-17
K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT2014-04-23

More clearances from Hgm Medical Laser Systems, Inc.

view all

K921300 — MODEL PC ARGON ION LASER1992-10-06
K913569 — COMPAC A, ELITE A, ELITE A PLUS, SURGICA A1991-10-17
K912628 — AIR ARGON ION LASERS VARIOUS MODELS1991-09-13
K910272 — HGM COMBINATION ND:YAG & SOLID STATE GREEN1991-08-09
K912438 — MODELS 5,8,20,20S ARGON ION LASERS1991-07-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.