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510(k) K880071

SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE by Laserguide — Product Code FCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1988
Date Received
January 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class
Class II
Regulation Number
876.4020
Review Panel
GU
Submission Type

Other clearances by Laserguide

  • K875104 — SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE (February 2, 1988)
  • K873892 — SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE (February 2, 1988)
  • K873664 — LIGHT-SPOT FIBEROPTIC LASER HANDPIECE (November 6, 1987)
  • K873571 — LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE (November 6, 1987)

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  • K923436 — ILLUMINATED URETERAL CATHETER (March 5, 1993)
  • K874680 — LASEGUIDE 600A, 600B, 400A, AND 400B (March 23, 1988)