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510(k) K871579

MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE by Sharplan Lasers, Inc. — Product Code HHR

K871579 is an FDA 510(k) premarket notification submitted by Sharplan Lasers, Inc. for the device "MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE". The FDA issued a decision of Substantially Equivalent on November 16, 1987. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Sharplan Lasers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1987
Date Received
April 23, 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 Sharplan Lasers, Inc.

  • K973354 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (December 4, 1997)
  • K972099 — SHARPLAN EPITOUCH RUBY LASER SYSTEM (August 27, 1997)
  • K971874 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (August 18, 1997)
  • K971648 — SHARPLAN ERBIUM: YAG LASER (4020) (July 23, 1997)
  • K971743 — SHARPLAN CO2 SURGICAL LASER SYSTEM (July 18, 1997)
  • K962446 — SHARPLAN RUBY LASER SYSTEM (March 7, 1997)
  • K963229 — SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS (November 5, 1996)
  • K961935 — SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER (November 1, 1996)
  • K962974 — SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) (August 21, 1996)
  • K961279 — SHARPLAN LASERS, INC. RUBY LASER SYSTEM (June 18, 1996)

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