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Vela Xl

by Starmedtec GmbH

510(k) K103654

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103654 Date6 Apr 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vela XL is a Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology (Regulation Number: 21 CFR 878.4810), classified as a Class II device under FDA regulations. It delivers high-power laser energy for precise tissue ablation, coagulation, and vaporisation, primarily in dermatological and surgical procedures requiring controlled thermal effects.

This device is supplied as a standalone console and is intended for use in clinical settings by trained personnel. It operates with a 50W Laser and 120W Thulium Laser, with specifications tailored for procedures such as tissue resurfacing, tumour ablation, and other dermatological interventions. The Vela XL is single-use or reusable (as per manufacturer maintenance protocols) and must be handled in accordance with sterile or non-sterile surgical protocols, depending on the procedure. Authorised under FDA 510(k) clearance (K103654), it adheres to regulatory standards for laser safety and electromagnetic compatibility.

Other devices from Starmedtec GmbH

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of medical procedures is the Vela XL primarily designed for, and how does it differ from other laser devices in its class?

    The Vela XL is specifically designed for general and plastic surgery, as well as dermatology, where controlled tissue ablation, coagulation, and vaporisation are required. It features a 50W Laser and a 120W Thulium Laser, making it suitable for procedures like tissue resurfacing and tumor ablation. Unlike some laser devices that focus on cosmetic treatments alone, the Vela XL is also intended for surgical applications, offering versatility in clinical settings for trained personnel.

  • Is the Vela XL meant for single-use or reusable applications, and what considerations should be taken for its maintenance?

    The Vela XL can be used either as a single-use device or reused, depending on the clinical protocol and procedure requirements. If reused, it must follow the manufacturer’s maintenance protocols to ensure safety and performance. Sterility protocols will vary—some applications may require sterile handling, while others may allow non-sterile use, so proper cleaning and upkeep are critical to prevent contamination and maintain laser efficacy.

  • What regulatory pathway did the Vela XL follow to gain market authorization, and what does that mean for its safety and compliance?

    The Vela XL was authorized through the FDA 510(k) clearance process (K103654), which determines that it is substantially equivalent to a legally marketed device already on the market. This means it meets FDA standards for laser safety and electromagnetic compatibility, ensuring it adheres to strict regulatory requirements before being approved for clinical use in the U.S. The classification as a Class II device further indicates it undergoes additional controls beyond general controls.

  • How is the Vela XL supplied, and what should clinicians expect when integrating it into their practice?

    The Vela XL is supplied as a standalone console, meaning it is a complete system designed for clinical use by trained personnel. Clinicians should expect a dedicated unit that requires proper setup in a controlled environment, such as an operating room or dermatology clinic. Since it is intended for high-power laser applications, facilities must ensure proper ventilation, safety protocols, and staff training to operate it effectively and safely.