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510(k) K874837

KTP/532 LASER FOR OB-GYN USE by Laserscope — Product Code HHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1988
Date Received
November 24, 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 Laserscope

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  • K061646 — LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES (June 27, 2006)
  • K034011 — GEMINI SURGICAL LASER SYSTEM & ACCESSORIES (March 30, 2004)
  • K024206 — AURA ISURGICAL LASER SYSTEM & ACCESSORIES (November 17, 2003)
  • K020021 — LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) (July 2, 2002)
  • K010834 — LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES (May 21, 2001)
  • K010284 — LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (May 1, 2001)
  • K003765 — LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (March 6, 2001)
  • K003147 — LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) (December 15, 2000)
  • K990718 — ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) (March 8, 2000)

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)
  • K875078 — HERACURE LS 500 (February 22, 1988)
  • K872709 — MODEL 20-C, RL-20A/U, OB-10A/U (February 2, 1988)