Dornier Medilas H

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K001243 ↗

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 H/2

  Class II

  FDA 510(k) K984591 Active Cleared 26 Mar 1999

See all devices from Dornier Surgical Products, Inc. →

• What is the Dornier Medilas H used for?

  The Dornier Medilas H is designed for cutting, vaporization, ablation, and coagulation of soft tissue. It is intended for use with endoscopic equipment such as laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes, and can be used in both contact and non-contact modes for incision, excision, and tissue treatment in surgical and endoscopic settings.

• Is the Dornier Medilas H a reusable or single-use device?

  The Dornier Medilas H is a reusable system, as indicated by the availability of a service manual. It requires regular service and maintenance to ensure proper function and safety, and is not intended for single-use disposal.

• How is the Dornier Medilas H supplied and what regulatory pathway was used?

  The Dornier Medilas H is supplied as a medical laser system and received FDA 510(k) clearance under product code GEX. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission, with clearance granted on May 24, 2000.