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510(k) K914484

LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE by Hgm Medical Laser Systems, Inc. — Product Code HLI

K914484 is an FDA 510(k) premarket notification submitted by Hgm Medical Laser Systems, Inc. for the device "LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE". The FDA issued a decision of Substantially Equivalent on January 6, 1992. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Hgm Medical Laser Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1992
Date Received
October 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Hgm Medical Laser Systems, Inc.

  • K921300 — MODEL PC ARGON ION LASER (October 6, 1992)
  • K913569 — COMPAC A, ELITE A, ELITE A PLUS, SURGICA A (October 17, 1991)
  • K912628 — AIR ARGON ION LASERS VARIOUS MODELS (September 13, 1991)
  • K910272 — HGM COMBINATION ND:YAG & SOLID STATE GREEN (August 9, 1991)
  • K912438 — MODELS 5,8,20,20S ARGON ION LASERS (July 17, 1991)
  • K910602 — HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY (June 24, 1991)
  • K911104 — PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 (June 11, 1991)
  • K910898 — SURGICA(TM) H (May 31, 1991)
  • K904699 — COMPAC(TM) DIODE LASERS (April 25, 1991)
  • K904700 — ENDOCOAGULATOR KRS568(TM) LASER (February 19, 1991)

Other clearances for product code HLI

  • K153080 — RTVue XR OCT Avanti with AngioVue Software (February 11, 2016)
  • K150722 — EnFocus 2300, EnFocus 4400 (December 2, 2015)
  • K142953 — OCT-Camera (March 4, 2015)
  • K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (September 17, 2014)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)
  • K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES (March 26, 2014)
  • K133892 — IVUE 500 (March 19, 2014)
  • K123316 — HEINE OMEGA 500 (February 26, 2013)
  • K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)

FDA data resources