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510(k) K874255

ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. by Minnesota Laser Corp. — Product Code LNK

K874255 is an FDA 510(k) premarket notification submitted by Minnesota Laser Corp. for the device "ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.". The FDA issued a decision of Substantially Equivalent on July 12, 1988. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Minnesota Laser Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1988
Date Received
October 20, 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 Minnesota Laser Corp.

  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS (March 4, 1988)
  • K854473 — PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC (June 20, 1986)
  • K854468 — PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC (June 20, 1986)
  • K854471 — PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T (February 13, 1986)
  • K854472 — PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG (February 11, 1986)
  • K854469 — PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG (February 11, 1986)
  • K854470 — PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI (February 7, 1986)
  • K852694 — PORTALASE 200 CARBON SURGICAL LASER SYSTEM (September 30, 1985)
  • K852696 — FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY (September 19, 1985)

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)
  • 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