Powered Laser Surgical Instrument

Product Code: GEX

General & Plastic Surgery Medical Laser Products

Definition: "a Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podi

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 878.4810


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as GEX

5654Powered Laser Surgical InstrumentLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5654Powered Laser Surgical InstrumentLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Powered Laser Surgical Instrument [32410]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument [30278]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument [38651]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument [38649]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument [38650]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument [34006]21 CFR §878.4810 🔎

Pre-market Notifications for GEX

K212978Diode Laser Therapy SystemBEIJING UNT Technology Co., Ltd
K212502Resonic Rapid Acoustic Pulse DeviceSoliton Inc.
K212270DEKA LipoAIEL.EN Electronic Engineering Spa
K212082PicoreBio-Med USA Inc
K211761UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering
K211735CO2 Laser Machine, Model: BW-203BZhengzhou Bestview St Co., Ltd.
K211637AROMA GRANDDaeju Meditech Engineering Co., Ltd.
K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, And Accessories)Gyrus ACMI, Inc.
K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview St Co., Ltd.
K211362SCAR 3EL. En Electronic Engineering SPA
K210951Leonardo Mini BlueCeramOptec GmbH
K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser FiberBoston Scientific
K210226PicoSure WorkstationCynosure LLC
K210142Fiber DustQuanta System Spa
K210033Laser Treatment System, Model: NYX And GraceCanadian Pioneer Medical Technology Corporation

Global Unique Device Identification Database

00408939Powered Laser Surgical Instrument
00408919Powered Laser Surgical Instrument
00380657504480Powered laser surgical instrument
00366975012913Powered Laser Surgical Instrument
00366975012906Powered Laser Surgical Instrument
00366975012890Powered Laser Surgical Instrument
00366975003676Powered Laser Surgical Instrument
00366975003669Powered Laser Surgical Instrument
00366975003652Powered Laser Surgical Instrument
00366975003645Powered Laser Surgical Instrument
00366975003638Powered Laser Surgical Instrument
10632307002073Powered laser surgical instrument
10632307002066Powered laser surgical instrument
10632307002028Powered laser surgical instrument
10632307001892Powered laser surgical instrument

Maude Adverse Events

PDBLASER INSTRUMENT, SURGICAL, POWEREDUS SURGICAL PUERTO RICO2020-03-31
LIGHTTRAIL TRACTIPBOSTON SCIENTIFIC CORPORATION2020-03-31
ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBERBOSTON SCIENTIFIC CORPORATION2020-03-31
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-31
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-31
WAVELIGHT FS200 FEMTOSECOND LASERWAVELIGHT GMBH2020-03-31
LITHOQUANTA SYSTEM S.P.A.2020-03-31
VENACURE 1470 PROQUANTA SYSTEM S.P.A.2020-03-31
COOK? SINGLE-USE HOLMIUM LASER FIBERCOOK INC2020-03-31
WAVELIGHT FS200 FEMTOSECOND LASERWAVELIGHT GMBH2020-03-31
WAVELIGHT FS200 FEMTOSECOND LASERWAVELIGHT GMBH2020-03-31
FLEXIVABOSTON SCIENTIFIC CORPORATION2020-03-31
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-30
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-30
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-30
LIGHTTRAIL SINGLE USEBOSTON SCIENTIFIC CORPORATION2020-03-30
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-30
CYBER TM 120QUANTA SYSTEM S.P.A.2020-03-30
OLYMPUS EMPOWER H35QUANTA SYSTEM S.P.A.2020-03-30
LIGHTTRAIL SINGLE USEBOSTON SCIENTIFIC CORPORATION2020-03-30
WAVELIGHT FS200 FEMTOSECOND LASERWAVELIGHT GMBH2020-03-30
COOK? SINGLE-USE HOLMIUM LASER FIBERCOOK INC2020-03-30
LIGHTTRAIL SINGLE USEBOSTON SCIENTIFIC CORPORATION2020-03-30
LIGHTTRAIL SINGLE USEBOSTON SCIENTIFIC CORPORATION2020-03-30
LIGHTTRAIL SINGLE USEBOSTON SCIENTIFIC CORPORATION2020-03-30
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-27
PICOWAY2020-03-27
PICOSURECYNOSURE LLC2020-03-27
NEUROBLATE? SYSTEMMONTERIS MEDICAL2020-03-27
NEUROBLATE? SYSTEMMONTERIS MEDICAL2020-03-27
NEUROBLATE? SYSTEMMONTERIS MEDICAL2020-03-27
WAVELIGHT FS200 FEMTOSECOND LASERWAVELIGHT GMBH2020-03-27
WAVELIGHT FS200 FEMTOSECOND LASERWAVELIGHT GMBH2020-03-27
GENTLEMAX PROCANDELA CORPORATION2020-03-26
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-26
FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBERBOSTON SCIENTIFIC CORPORATION2020-03-26
LIGHTTRAIL REUSABLEBOSTON SCIENTIFIC CORPORATION2020-03-26
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT XPS LASER SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT HPS BPH FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
GREENLIGHT MOXY FIBER OPTICBOSTON SCIENTIFIC CORPORATION2020-03-25
LUMENIS PULSE120HLUMENIS LTD.2020-03-25
VERSAPULSE POWERSUITE 60WLUMENIS LTD.2020-03-25

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