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510(k) K951033

ANDELA DYNAMIC COOLING DEVICE by Candela Laser Corp. — Product Code IMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1996
Date Received
March 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

Other clearances by Candela Laser Corp.

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  • 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)
  • K943292 — CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS (March 9, 1995)

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