FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K221268 |
AVAVA, Inc |
SR-1 Skin Treatment System |
11/21/2022 |
K223871 |
Avava, Inc. |
Miria Skin Treatment System |
06/22/2023 |
K202884 |
AVAVA, Inc. |
SR-1 Skin Treatment System |
04/13/2021 |
K162398 |
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. |
CO2 Laser Therapy Systems |
07/06/2017 |
K111831 |
BIO-MED U.S.A., INC. |
MX-7000 MICROXEL |
12/19/2011 |
K131903 |
ECLIPSE AESTHETICS, LLC |
EQUINOX CO2 LASER |
09/19/2013 |
K100487 |
ECLIPSEMED GLOBAL, INC |
EQUINOX CO2 LASER SYSTEM |
11/29/2010 |
K110333 |
FOCUS MEDICAL, LLC. |
NATURALASE CO2 LASER SYSTEM |
04/12/2012 |
K180036 |
IDS, LTD. |
SMAXEL CO2 Surgical Laser System |
02/02/2018 |
K182498 |
Jiangsu Unimed Laser Technology Co., Ltd. |
Advanced Skin Renewing Device |
11/30/2018 |
K100590 |
JM SYSTEM CO., LTD. |
EDGE CO2 LASER SYSTEM |
11/10/2010 |
K110984 |
LASERING S.R.L. |
SLIM E30 II CO2 LASER |
07/22/2011 |
K130028 |
LUMENIS, LTD. |
RESURFX 1565NM LASER MODULE |
09/03/2013 |
K100610 |
LUTRONIC CORPORATION |
LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS |
01/20/2011 |
K111840 |
PALOMAR MEDICAL PRODUCTS, INC. |
EMERGE FRACTIONAL LASER |
11/14/2011 |
K090525 |
PALOMAR MEDICAL PRODUCTS, INC. |
LOI SYSTEM |
06/01/2009 |
K091446 |
PALOMAR MEDICAL PRODUCTS, INC. |
MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE |
10/27/2009 |
K101506 |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES |
09/01/2010 |
K103664 |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
PRIMUS AESTHETIC PLATFORM |
03/17/2011 |
K213332 |
Paradigm Medical Corporation |
Multifrax Laser System |
06/03/2022 |
K090639 |
QUANTEL DERMA GMBH |
EXELO2, MODEL 4010 |
10/29/2009 |
K221770 |
Shanghai Apolo Medical Technology Co., Ltd. |
Fiber Laser Treatment System |
10/13/2022 |
K120433 |
SOLTA MEDICAL, INC. |
CLEAR + BRILLIANT LASER SYSTEM |
04/02/2012 |
K110349 |
SOLTA MEDICAL, INC. |
CLEAR+BRILLIANT LASER SYSTEM |
05/03/2011 |
K091420 |
SOLTA MEDICAL, INC. |
FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 |
10/14/2009 |
K141046 |
SRMC CO., LTD |
MIDI-SRS |
12/24/2014 |
K101490 |
THERMAGE, INC. |
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US |
09/08/2010 |
K130459 |
TRIA BEAUTY, INC. |
TRIA FAN SYSTEM |
10/25/2013 |
K141868 |
TRIA BEAUTY, INC. |
TRIA FANP |
12/30/2014 |
K192350 |
Wingderm Electro-Optics Ltd. |
Medical Non-Ablative Fractional Laser Systems |
04/30/2020 |