Laser System MedioStar H (With and Without Skin Cooling System)

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

510(k) Number

K994116 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the Laser System MedioStar H intended for?

  The Laser System MedioStar H is intended to remove unwanted body hair and vascular lesions. It is designed for use by licensed professionals in the United States, as stated in the device description.

• How is the Laser System MedioStar H supplied or configured?

  The device is available in two configurations: one without a cooling system (MeDioStar H) and one with an integrated skin cooling system (MeDioStar HC). This allows users to choose based on their clinical needs for patient comfort during treatment.

• Who is authorized to use the Laser System MedioStar H?

  The device is restricted to sale to or use by licensed professionals in the United States. This restriction ensures that only qualified individuals operate the laser system for hair and vascular lesion removal.

• What regulatory pathway was used for the Laser System MedioStar H?

  The Laser System MedioStar H received FDA 510(k) clearance under K994116, as indicated in the authorizations and device data. This means it was found substantially equivalent to a legally marketed predicate device.