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510(k) K925395

TECHNOMED PULSOLITH 4000 LASER SYSTEM by Teknomed, Inc. — Product Code LNK

K925395 is an FDA 510(k) premarket notification submitted by Teknomed, Inc. for the device "TECHNOMED PULSOLITH 4000 LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on May 21, 1993. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Teknomed, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1993
Date Received
October 26, 1992
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 Teknomed, Inc.

  • K913917 — MULTILASE 2100 C, 2100 D (November 5, 1992)
  • K920708 — MULTILASE 2500 A (November 5, 1992)
  • K913290 — MULTILASE 2100 A (February 21, 1992)
  • K895178 — TECHNOMED PULSOLITH LASER SYSTEM (October 6, 1989)
  • K890436 — TECHNOMED PULSOLITH LASER SYSTEM (March 23, 1989)
  • K790132 — TECNOTOMO (February 21, 1979)

Other clearances for product code LNK

  • 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)
  • K873892 — SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE (February 2, 1988)

FDA data resources