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510(k) K871220

MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. by Cooper Lasersonics, Inc. — Product Code HHR

K871220 is an FDA 510(k) premarket notification submitted by Cooper Lasersonics, Inc. for the device "MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.". The FDA issued a decision of Substantially Equivalent on July 16, 1987. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Cooper Lasersonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1987
Date Received
March 20, 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 Cooper Lasersonics, Inc.

  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K880429 — ILLUMINA 55 CO2 LASER SYSTEM (April 18, 1988)
  • K880807 — ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880809 — ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880808 — ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880428 — ILLUMINA 25 CO2 LASER SYSTEM (April 18, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (March 24, 1988)
  • K880172 — MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. (March 11, 1988)

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