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510(k) K881507

ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES by Hgm Medical Laser Systems, Inc. — Product Code HHR

K881507 is an FDA 510(k) premarket notification submitted by Hgm Medical Laser Systems, Inc. for the device "ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on April 27, 1989. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Hgm Medical Laser Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1989
Date Received
April 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
Submission Type

Other clearances by Hgm Medical Laser Systems, Inc.

  • K921300 — MODEL PC ARGON ION LASER (October 6, 1992)
  • 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 HHR

  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
  • K874615 — LASER CANNISTER FILTER (June 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)
  • K872709 — MODEL 20-C, RL-20A/U, OB-10A/U (February 2, 1988)

FDA data resources