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510(k) K914484

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

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.

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  • 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)

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