Powered Laser Surgical Instrument With Microbeam\fractional Output

Product Code: ONG

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. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic To Destroy, Remove Or Coagulat

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 ONG

5817Powered Laser Surgical Instrument With Microbeam\fractional OutputLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5817Powered Laser Surgical Instrument With Microbeam\fractional OutputLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Powered Laser Surgical Instrument With Microbeam\Fractional Output [30278]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument With Microbeam\Fractional Output [38651]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument With Microbeam\Fractional Output [38649]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument With Microbeam\Fractional Output [38650]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument With Microbeam\Fractional Output [34006]21 CFR §878.4810 🔎
Powered Laser Surgical Instrument With Microbeam\Fractional Output [29958]21 CFR §878.4810 🔎

Pre-market Notifications for ONG

K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.
K213332Multifrax Laser SystemParadigm Medical Corporation
K182498Advanced Skin Renewing DeviceJiangsu Unimed Laser Technology Co., Ltd.
K180036SMAXEL CO2 Surgical Laser SystemIDS, LTD.
K162398CO2 Laser Therapy SystemsBEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO.
K141868TRIA FANPTRIA BEAUTY, INC.
K141046MIDI-SRSSRMC CO., LTD
K131903EQUINOX CO2 LASERECLIPSE AESTHETICS, LLC
K130459TRIA FAN SYSTEMTRIA BEAUTY, INC.
K130028RESURFX 1565NM LASER MODULELUMENIS, LTD.
K120433CLEAR + BRILLIANT LASER SYSTEMSOLTA MEDICAL, INC.
K111840EMERGE FRACTIONAL LASERPALOMAR MEDICAL PRODUCTS, INC.
K111831MX-7000 MICROXELBIO-MED U.S.A., INC.
K110984SLIM E30 II CO2 LASERLASERING S.R.L.
K110349CLEAR+BRILLIANT LASER SYSTEMSOLTA MEDICAL, INC.

Global Unique Device Identification Database

00865601000336Powered Laser Surgical Instrument With Microbeam\Fractional Output
00860564000324Powered Laser Surgical Instrument With Microbeam\Fractional Output
00850608002704Powered Laser Surgical Instrument With Microbeam\Fractional Output
00850608002698Powered Laser Surgical Instrument With Microbeam\Fractional Output
00850608002681Powered Laser Surgical Instrument With Microbeam\Fractional Output
00850608002674Powered Laser Surgical Instrument With Microbeam\Fractional Output
00850608002667Powered Laser Surgical Instrument With Microbeam\Fractional Output
00850608002650Powered Laser Surgical Instrument With Microbeam\Fractional Output
00850608002643Powered Laser Surgical Instrument With Microbeam\Fractional Output
00850608002636Powered Laser Surgical Instrument With Microbeam\Fractional Output
07290109143040Powered Laser Surgical Instrument With Microbeam\Fractional Output
07290109142388Powered Laser Surgical Instrument With Microbeam\Fractional Output
07290109142364Powered Laser Surgical Instrument With Microbeam\Fractional Output
07290109140377Powered Laser Surgical Instrument With Microbeam\Fractional Output
07290109140285Powered Laser Surgical Instrument With Microbeam\Fractional Output

Maude Adverse Events

CLEAR + BRILLIANT LASER SYSTEMSOLTA MEDICAL INC.2020-02-12
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2019-12-04
CLEAR + BRILLIANT LASER SYSTEMSOLTA MEDICAL INC.2019-11-06
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2019-10-02
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2019-10-02
FRAXEL LASER RESURFACING RESTORESOLTA MEDICAL, INC.2019-09-25
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2019-09-25
CLEAR + BRILLIANT LASER SYSTEMSOLTA MEDICAL2019-07-10
CLEAR + BRILLIANT LASER SYSTEMSOLTA MEDICAL2019-05-10
FRAXEL RESTORE 1550SOLTA MEDICAL, INC.2019-04-25
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL, INC.2019-03-12
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL INC2019-03-05
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL INC2019-03-05
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL INC.2019-02-14
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2019-02-01
BD PHASEAL? PROTECTOR P14BECTON DICKINSON, S.A.2019-01-25
CLEAR + BRILLIANT LASER SYSTEMSOLTA MEDICAL2018-12-20
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2018-12-03
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2018-11-27
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2018-11-19
CLEAR + BRILLIANT LASER SYSTEMSOLTA MEDICAL2018-11-16
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL INC.2018-11-14
CLEAR + BRILLIANT LASER SYSTEMSOLTA MEDICAL2018-11-02
CLEAR + BRILLIANT LASER SYSTEMSOLTA MEDICAL2018-09-06
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2018-08-24
BD PHASEAL? INJECTOR LUER LOCK N35BECTON DICKINSON, S.A.2018-07-12
BD PHASEAL? INJECTOR LUER LOCK N35BECTON DICKINSON, S.A.2018-07-11
BD PHASEAL? INJECTOR LUER LOCK N35BECTON DICKINSON, S.A.2018-06-29
THERMAGE TIPSOLTA MEDICAL, INC.2018-06-22
C+B PELO SYSTEMGME GERMAN MEDICAL ENGINEERING2018-06-13
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2018-05-25
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL, INC.2018-05-04
BD PHASEAL? INJECTOR LUER LOCK N35BECTON DICKINSON, S.A.2018-03-22
BD?PHASEAL? INJECTOR LUER LOCK N35CBECTON DICKINSON, S.A.2018-03-20
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL, INC.2018-03-16
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL, INC.2018-03-16
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL, INC.2018-03-16
FRACTIONAL CO2 40C LASERSHARPLAN / LUMENIS2018-03-05
FRAXEL RE:STORE LASER SYSTEMSOLTA MEDICAL2018-02-27
BD PHASEAL? PROTECTOR P14BECTON DICKINSON, S.A.2018-02-19
BD PHASEAL? INJECTOR LUER LOCK N35BECTON DICKINSON, S.A.2018-02-14
BD?PHASEAL? INJECTOR LUER LOCK N35CBECTON DICKINSON, S.A.2018-02-09
BD PHASEAL? PROTECTOR P14BECTON DICKINSON, S.A.2018-01-09
BD PHASEAL? INJECTOR LUER LOCK N35BECTON DICKINSON, S.A.2018-01-08
TRIA BEAUTYTRIA BEAUTY2017-12-29
FRAXEL RE:STORE DUAL LASER SYSTEMSOLTA MEDICAL INC.2017-12-27
BD PHASEAL? PROTECTOR P50JBECTON DICKINSON, S.A.2017-12-20
BD PHASEAL? INJECTOR LUER LOCK N35BECTON DICKINSON, S.A.2017-12-04
BD?PHASEAL? INJECTOR LUER LOCK N35CBECTON DICKINSON, S.A.2017-12-01
BD PHASEAL? INJECTOR LUER LOCK N35BECTON DICKINSON, S.A.2017-11-28

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