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510(k) K901723

MDL-2000 LASERTRIPTER by Candela Laser Corp. — Product Code LNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1990
Date Received
April 16, 1990
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

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Other clearances for product code LNK

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  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (April 14, 1988)
  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY 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)