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

K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.
K200659Dermalux Tri-Wave MDAesthetic Technology Ltd.
K200331Rapid Acoustic Pulse DeviceSoliton Inc.
K200234Surgical Laser FibersQuanta System Spa
K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.
K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.
K200110SANDRO DualWON TECH Co., Ltd.
K193656SkyPulseFotona D.o.o.
K193661LightWalker Laser System FamilyFotona D.o.o.
K193609Q Switched Nd: YAG Laser MachineBeijing Lead Beauty S & T Co., Ltd
K193500Stellar M22 For Intense Pulsed Light (IPL) And Laser SystemLumenis Ltd.
K193486Epic 980Biolase, Inc
K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.
K193478XTRAC Momentum Excimer Laser SystemStrata Skin Sciences, Inc.
K193446Bare: 808LUVO Medical Technologies, Inc

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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