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510(k) K871875

MODEL 5050 SURGILASER FOR OB-GYN USE by Lasermatic, Inc. — Product Code HHR

K871875 is an FDA 510(k) premarket notification submitted by Lasermatic, Inc. for the device "MODEL 5050 SURGILASER FOR OB-GYN USE". The FDA issued a decision of Substantially Equivalent on August 22, 1988. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Lasermatic, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1988
Date Received
May 14, 1987
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 Lasermatic, Inc.

  • K903131 — LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM (February 19, 1991)
  • K901638 — MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 (June 27, 1990)
  • K895279 — LASERMATIC COMBOLASER MODEL 5050 (November 8, 1989)
  • K893529 — COMBOLASER MODEL 5050 (June 8, 1989)
  • K870587 — LASERMATIC SURGILASER MODEL 5050 (August 10, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)
  • K871876 — MODEL 5050 SURGILASER FOR PULMONARY USE (January 22, 1988)
  • K871933 — MODEL 5050 SURGILASER FOR NEUROSURGERY USE (January 22, 1988)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • 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)
  • K870841 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN (February 2, 1988)

FDA data resources