Home / 510(k) Clearances / K880256

510(k) K880256

MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE by Sharplan Lasers, Inc. — Product Code LNK

K880256 is an FDA 510(k) premarket notification submitted by Sharplan Lasers, Inc. for the device "MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE". The FDA issued a decision of Substantially Equivalent on April 14, 1988. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Sharplan Lasers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1988
Date Received
January 20, 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 Sharplan Lasers, Inc.

  • K973354 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (December 4, 1997)
  • K972099 — SHARPLAN EPITOUCH RUBY LASER SYSTEM (August 27, 1997)
  • K971874 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (August 18, 1997)
  • K971648 — SHARPLAN ERBIUM: YAG LASER (4020) (July 23, 1997)
  • K971743 — SHARPLAN CO2 SURGICAL LASER SYSTEM (July 18, 1997)
  • K962446 — SHARPLAN RUBY LASER SYSTEM (March 7, 1997)
  • K963229 — SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS (November 5, 1996)
  • K961935 — SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER (November 1, 1996)
  • K962974 — SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) (August 21, 1996)
  • K961279 — SHARPLAN LASERS, INC. RUBY LASER SYSTEM (June 18, 1996)

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)
  • 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)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 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