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510(k) K871934

MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE by Lasermatic, Inc. — Product Code LNK

K871934 is an FDA 510(k) premarket notification submitted by Lasermatic, Inc. for the device "MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE". The FDA issued a decision of Substantially Equivalent on March 25, 1988. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Lasermatic, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1988
Date Received
May 19, 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 Lasermatic, Inc.

  • K903131 — LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM (February 19, 1991)
  • K901638 — MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 (June 27, 1990)
  • K895279 — LASERMATIC COMBOLASER MODEL 5050 (November 8, 1989)
  • K893529 — COMBOLASER MODEL 5050 (June 8, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K870587 — LASERMATIC SURGILASER MODEL 5050 (August 10, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871876 — MODEL 5050 SURGILASER FOR PULMONARY USE (January 22, 1988)
  • K871933 — MODEL 5050 SURGILASER FOR NEUROSURGERY USE (January 22, 1988)

Other clearances for product code LNK

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • K901723 — MDL-2000 LASERTRIPTER (July 13, 1990)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (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)
  • K873892 — SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE (February 2, 1988)

FDA data resources