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510(k) K861046

MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA by Sharplan Industries, Inc. — Product Code LNK

K861046 is an FDA 510(k) premarket notification submitted by Sharplan Industries, Inc. for the device "MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Sharplan Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
March 18, 1986
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 Industries, Inc.

  • K861044 — MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND (October 28, 1986)
  • K861047 — MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL (June 17, 1986)
  • K861045 — MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT (April 23, 1986)

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)
  • 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)

FDA data resources