Evlt Kit and the D15PLUS and D30PLUS Diode Lasers

• • Ongoing Z-1819-2022 FDA Class II ·initiated 10 Aug 2022

  OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention

510(k) Number

K041957 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Diomed 15 Diode Laser

  Class II

  FDA 510(k) K012398 Active Cleared 22 Jan 2002

• A100 Aesthetic Diode Laser

  Class II

  FDA 510(k) K000982 Active Cleared 1 May 2000

• Diomed 25 25W Surgical Diode Laser

  Class II

  FDA 510(k) K931776 Active Cleared 19 Oct 1993

• Diomed Delta 25

  Class II

  FDA 510(k) K063828 Active Cleared 25 Jan 2007

• Diomed 25 Surgical Diode Laser, Gynecology Applic

  Class II

  FDA 510(k) K914519 Active Cleared 16 Sep 1993

• Diomed 25 Surgical Diode Laser, Urology Applicat

  Class II

  FDA 510(k) K914520 Active Cleared 22 Jan 1993

See all devices from Diomed, Inc. →