Dornier Medilas H/2

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K984591 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Dornier Lasertrode Fiber

  Class II

  FDA 510(k) K991183 Active Cleared 9 Jun 1999

• Dornier Medilas H

  Class II

  FDA 510(k) K981718 Active Cleared 17 Jul 1998

• Dornier Scanner Handpiece

  Class II

  FDA 510(k) K993146 Active Cleared 8 Nov 1999

• Dornier Medilas D Skinpulse Laser System (Skinpulse)

  Class II

  FDA 510(k) K003993 Active Cleared 26 Mar 2001

• Dornier Medilas E

  Class II

  FDA 510(k) K981438 Active Cleared 20 Jul 1998

• Dornier Medilas D Skinpulse

  Class II

  FDA 510(k) K000072 Active Cleared 12 Jun 2000

See all devices from Dornier Surgical Products, Inc. →