Home / 510(k) Clearances / K901723

510(k) K901723

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

K901723 is an FDA 510(k) premarket notification submitted by Candela Laser Corp. for the device "MDL-2000 LASERTRIPTER". The FDA issued a decision of Substantially Equivalent on July 13, 1990. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Candela Laser Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by Candela Laser Corp.

  • K951033 — ANDELA DYNAMIC COOLING DEVICE (August 15, 1996)
  • K955662 — CANDELA Q-SWITCHED ALEXANDRITE LASERS (June 14, 1996)
  • K955011 — CANDELA HCS 2000 URETHERAL WARMER CATHETER (April 3, 1996)
  • K954872 — CANDELA CRYO-PROBE HOLDER (February 5, 1996)
  • K954934 — CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE (February 2, 1996)
  • K953412 — CANDELA MODEL PLTL-1 LASER SYSTEM (October 24, 1995)
  • K953294 — CANDELA CRYOSYSTEM CS-5 (October 18, 1995)
  • K950831 — ALEXLAZR (May 26, 1995)
  • K946386 — CANDELA RUBY LAZE Q-SWITCHED RUBY LASER (March 24, 1995)
  • K950661 — CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE (March 10, 1995)

Other clearances for product code LNK

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • 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)
  • K873892 — SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE (February 2, 1988)

FDA data resources