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510(k) K890787

O-020 LASER INDIRECT OPHTHALMOSCOPE by Hgm Medical Laser Systems, Inc. — Product Code HGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1989
Date Received
February 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Abortion Unit, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

Other clearances by Hgm Medical Laser Systems, Inc.

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  • K914484 — LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE (January 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)

Other clearances for product code HGF

  • K945179 — BOTTLE COLLECTION SET (January 26, 1995)
  • K905115 — BIOVISION ENDOCULAR PROBE (February 11, 1991)
  • K904248 — MODEL GLASE 210 HOLMIUM LASER SYSTEM (December 14, 1990)