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510(k) K820261

MONITOR CO2 LASER SYSTEM by Cooper Medical Corp. — Product Code HHR

K820261 is an FDA 510(k) premarket notification submitted by Cooper Medical Corp. for the device "MONITOR CO2 LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 5, 1982. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Cooper Medical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1982
Date Received
February 2, 1982
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 Cooper Medical Corp.

  • K840144 — YAG LASER 8000 GASTROINTESTINAL BLEE (May 18, 1984)
  • K833387 — ARGON LASER SURGICAL SYSTEM 770 (April 18, 1984)
  • K833497 — COOPER MEDICAL MODEL 770 (April 17, 1984)
  • K832703 — ARGON LASER SYS-MODEL 5000 (January 30, 1984)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • 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)

FDA data resources