|
Device |
powered laser surgical instrument |
Regulation Description |
Laser surgical instrument for use in general and plastic surgery and in dermatology. |
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, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light. |
Product Code | GEX |
Regulation Number |
878.4810
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
A.R.C. LASER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALCON |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALCON RESEARCH, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALMA LASERS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALMA LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMA NETWORK INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMBICARE HEALTH LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANGIODYNAMICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ASCLEPION LASER TECHNOLOGIES GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOLASE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOLASE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIO-MED USA INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO-MED USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOS S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BISON MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANDELA |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CANDELA CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CAO GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CLINICAL LASERTHERMIA SYSTEMS AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COLOPLAST CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLOPLAST MANUFACTURING US LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CUTERA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CYDEN LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIOTECH CO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DORNIER MEDTECH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DORNIER MEDTECH AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EL.EN. ELECTRONIC ENGINEERING SPA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ELLIPSE A/S |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
FORMATK SYSTEMS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
FOTONA D.O.O. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
GME GERMAN MEDICAL ENGINEERING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INMODE MD LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INNOVAQUARTZ LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IRIDEX CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IRIDEX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
JEISYS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LASER PERIPHERALS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LASEROPTEK CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIGHTSCALPEL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LITECURE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUMENIS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LUMENIS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
LUMENIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
LUTRONIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
LUTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
M&T SRL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MERIDIAN AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIDIAN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MONTERIS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MONTERIS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NOVIAN HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OD-OS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNIGUIDE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PATIENT POCKET, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISE LIGHT SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUANTA SYSTEM S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
QUANTA SYSTEM SPA |
|
SUBSTANTIALLY EQUIVALENT
|
18
|
QUANTA SYSTEM, S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUANTEL MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAJA TRADING COMPANY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROHRER AESTHETICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SCITON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SHANGHAI WONDERFUL OPTELECTRICS TECH. CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHARPLIGHT TECHNOLOGIES LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN GSD TECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SILHOUET-TONE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRATA SKIN SCIENCES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENUS CONCEPT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENUS CONCEPT USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIAX DENTAL LAB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIORA LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VITAGE LED LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WON TECH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
YERIM ENGINEERING CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZOLAR TECHNOLOGY & MFG CO. INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2016 |
2582 |
2591 |
2017 |
2974 |
2974 |
2018 |
3522 |
3522 |
2019 |
2708 |
2708 |
2020 |
2178 |
2178 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Aerolase Corporation |
II |
Jan-03-2020 |
2 |
Angiodynamics, Inc. |
II |
Aug-30-2019 |
3 |
Beijing Syntech Laser Co., Ltd |
II |
May-02-2018 |
4 |
Boston Scientific Corporation |
II |
Apr-24-2020 |
5 |
Boston Scientific Corporation |
II |
May-22-2019 |
6 |
Boston Scientific Corporation |
II |
Mar-05-2018 |
7 |
Candela Corporation |
II |
Oct-24-2019 |
8 |
Cook Inc. |
II |
Jun-14-2017 |
9 |
Cook Inc. |
II |
Jun-05-2017 |
10 |
Dornier Medtech America, Inc. |
II |
May-21-2019 |
11 |
Ellipse A/S |
II |
Jun-09-2016 |
12 |
Inova Lasers LLC |
II |
Nov-17-2020 |
13 |
Iridex Corporation |
II |
Mar-16-2018 |
14 |
Laserex Systems Inc. |
II |
Jun-06-2017 |
15 |
Leoni Fiber Optics GmbH |
II |
Dec-07-2018 |
16 |
Lumenis Limited |
II |
Oct-23-2016 |
17 |
Lumenis Ltd |
II |
May-13-2016 |
18 |
Medtronic Navigation, Inc. |
II |
May-06-2020 |
19 |
Medtronic Navigation, Inc. |
II |
Jul-19-2018 |
20 |
Medtronic Navigation, Inc. |
II |
Oct-18-2017 |
21 |
Medtronic Navigation, Inc. |
II |
Jul-03-2017 |
22 |
Medtronic Navigation, Inc. |
II |
May-16-2016 |
23 |
Medtronic Sofamor Danek USA Inc |
II |
Jul-23-2020 |
24 |
Monteris Medical Corp |
I |
Mar-20-2018 |
25 |
Monteris Medical Corp |
I |
May-16-2016 |
26 |
New Star Lasers, Inc. |
II |
Sep-30-2016 |
27 |
Ra Medical Systems, Inc. |
II |
Apr-01-2020 |
28 |
Strata Skin Sciences, Inc. |
II |
Mar-27-2017 |
29 |
Xintec Corp |
III |
Oct-18-2019 |
30 |
Xintec Corp |
II |
Aug-02-2017 |
|
|
|
|