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510(k) K880171

MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL by Cooper Lasersonics, Inc. — Product Code LNK

K880171 is an FDA 510(k) premarket notification submitted by Cooper Lasersonics, Inc. for the device "MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL". The FDA issued a decision of Substantially Equivalent on April 11, 1988. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Cooper Lasersonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1988
Date Received
January 15, 1988
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 Cooper Lasersonics, Inc.

  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K880429 — ILLUMINA 55 CO2 LASER SYSTEM (April 18, 1988)
  • K880808 — ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880807 — ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880428 — ILLUMINA 25 CO2 LASER SYSTEM (April 18, 1988)
  • K880809 — ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (March 24, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K880172 — MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. (March 11, 1988)
  • K875115 — INFRAGUIDE(TM) (February 26, 1988)

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)
  • 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