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510(k) K873892

SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE by Laserguide — Product Code LNK

K873892 is an FDA 510(k) premarket notification submitted by Laserguide for the device "SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE". The FDA issued a decision of Substantially Equivalent on February 2, 1988. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Laserguide has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1988
Date Received
September 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
Submission Type

Other clearances by Laserguide

  • K880071 — SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE (March 22, 1988)
  • K875104 — SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE (February 2, 1988)
  • K873664 — LIGHT-SPOT FIBEROPTIC LASER HANDPIECE (November 6, 1987)
  • K873571 — LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE (November 6, 1987)

Other clearances for product code LNK

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • K901723 — MDL-2000 LASERTRIPTER (July 13, 1990)
  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (April 14, 1988)
  • K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (April 14, 1988)
  • K875039 — ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (April 13, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)

FDA data resources