Dynamis Pro Family

510(k) Number

K213267 ↗

FDA product code

GEX

Device class

Class II

Regulation

21 CFR Part 878.4810

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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• COOLTOUCH, MODEL LC215, COOLLIPO by NEW STAR LASERS, INC.
• OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE by OptiMedica Corp.
• CANDELA SMOOTHBEAM LASER SYSTEM by Candela Corporation
• V-IPL Filter SR-580 VTL43030-3 by VIORA LTD
• MEGABEAM DENTAL FIBER by Ceram Optec, Inc.
• MODEL DLASER 1000 ND;YAG LASER SYSTEM by Sunrise Technologies, Inc.
• MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS by Active Optical Systems, Ltd./Efraim Bidas

• Dynamis Pro Family

  Class II

  FDA 510(k) K252723 Active Cleared 19 Sep 2026

• LightWalker Max M021-5AF/1 Max

  Class II

  CE/MDR FDA 510(k) K242202 Active Cleared 23 Aug 2024 +1authorizations

• AvalancheLase M071-2F/XP

  Class II

  CE/MDR FDA 510(k) K223540 Active Cleared 19 Jan 2023 +1authorizations

• QuantumStar, StarFormer M008-3T

  Class II

  FDA 510(k) ×2 Active Cleared 1 Jul 2024 GUDID on market

See all devices from FOTONA d.o.o. →