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

K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.
K222701MANTA LaserSQUALUS MED Ltd.
K222673Alexandrite And Nd:YAG Laser Models CANLASE And TORLASECanadian Pioneer Medical Technology Corporation (CPMT LASER)
K222629Resonic Rapid Acoustic Pulse DeviceZeltiq Aesthetics, Inc.
K222555Reepot Nd; YAG Laser SystemIlooda Co., Ltd.
K222369PURE LaserEndymed Medical, Ltd.
K222109Accure LaserAccure Acne, Inc.
K222064The Alma Soprano TitaniumAlma Lasers Inc.
K221712Fotona XPulse Laser System Family (XPulse 1064 Nm, XPulse 810 Nm, XPulse 980 Nm)Fotona D.o.o.
K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.
K221571InMode Multi-systemInMode Ltd.
K221427V-LaserWON TECH Co., Ltd.
K221312Diode Laser Hair Removal DeviceGuangzhou CHUANG ZAO MEI Technology Co., Ltd
K220853PicoWay Laser SystemCandela Corporation
K220793InnoVoyce Laser FiberInnoVoyce LLC

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
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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
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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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