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510(k) K875039

ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY by Surgilase, Inc. — Product Code LNK

K875039 is an FDA 510(k) premarket notification submitted by Surgilase, Inc. for the device "ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY". The FDA issued a decision of Substantially Equivalent on April 13, 1988. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Surgilase, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1988
Date Received
December 7, 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 Surgilase, Inc.

  • K932421 — SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE (October 15, 1993)
  • K924664 — SURGILASE FIBERLASE CO2 LASER WAVEGUIDE (April 15, 1993)
  • K905006 — SURGILASE SL 150 SURGICAL LASER SYSTEM (February 21, 1991)
  • K904203 — SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM (December 7, 1990)
  • K902211 — SURGILASE YAG 100 SURGICAL LASER SYSTEM (June 29, 1990)
  • K900570 — SURGILASE YAG 100 IN ORTHOPEDIC SURGERY (May 1, 1990)
  • K901227 — SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 (April 26, 1990)
  • K901211 — SURGILASE SL50 SURGICAL LASER SYSTEM (April 26, 1990)
  • K894471 — SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY (November 14, 1989)
  • K894396 — SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER (August 7, 1989)

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)
  • 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