FDA 510(k) Applications for Medical Device:
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K090837 | ADVANCED MEDICAL PHOTONICS |
1384 VIA COLONNA TERRANCE | DAVIS | CA | 95618 |
| K102857 | AHWON MEDI INSTRUMENT CO., LTD |
111 ELLISON STREET | PATERSON | NJ | 07505 |
| K141237 | ALMA INC. |
26 REBECCA CT. | HOMOSASSA | FL | 34446 |
| K181298 | Alma Lasers Inc. |
485 Half Day Rd, Suite #100 | Buffalo Grove | IL | 60089 |
| K161286 | BEIJING ADSS DEVELOPMENT CO., LTD |
F6, XIANDAO BLDG.,JINYUAN RD. 36, DAXING ECONOMIC | BEIJING | 102628 | |
| K220385 | Beijing Globalipl Development Co., Ltd. |
F-8 Qunyinghui Building, Jinyuan Rd.32, | Beijing | 102628 | |
| K193328 | Beijing Globalipl Development Co., Ltd. |
F-8 Qunyinghui Building, Jinyuan Rd.32 | Beijing | 102628 | |
| K131859 | BEIJING HONKON TECHNOLOGIES CO., LTD |
P.O. BOX 120-119 | SHANGHAI | 200030 | |
| K122995 | BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. |
P.O. BOX 237-023 | SHANGHAI | 200237 | |
| K123435 | BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD |
7TH FLOOR 982 CONGYUN ROAD, BAIYUN DISTRICT | GUANGZHOU, GUANGDONG | 510420 | |
| K101901 | BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPMENT |
SUITE 5D NO. 19 LANE 999 | SHANGHAI SHANGHAI | 200030 | |
| K192519 | Beijing Superlaser Technology Co., Ltd. |
No.2 Zhongfu Street, Economic and Technological | Xihongmen Town, Daxing District, Beijing | 100076 | |
| K150051 | BTL Industries, Inc. |
47 Loring Drive | Framingham | MA | 01702 |
| K093168 | DERMEO |
1468 Harwell Avenue | Crofton | MD | 21114 |
| K200616 | E-SWIN |
Rue des Cotes D'orval, ZA de la prevote | Houdan | 78550 | |
| K093465 | ECLIPSEMED GLOBAL, INC |
16850 DALLAS PARKWAY | DALLAS | TX | 75248 |
| K082040 | EL.EN. ELECTRONIC ENGINEERING SPA |
17 VIA BALDANZESE | CALENZANO | 50041 | |
| K140670 | ELLIPSE A/S |
AGERN ALLE 11 | HOERSHOLM | DK-2970 | |
| K160195 | FORMATK SYSTEMS LTD. |
3 HAYOZMA ST. | TIRAT HACARMEL | 3903203 | |
| K082484 | GENESIS BIOSYSTEMS, INC. |
1500 EAGLE COURT | LEWISVILLE | TX | 75057 |
| K140668 | GLOBAL MEDICAL TECHNOLOGY S.L. |
C/ Isla de Alegranza 2 | San Sebastian de los Reyes | 28703 | |
| K181868 | IDS, Ltd. |
#105, Byoksan Digital Valley 3 cha 271, Digital-ro, Guro-gu | Seoul | 08381 | |
| K143339 | ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) |
KOCHAV YOKNEAM BLDG. YOKNEAM INDUSTRIAL ZONE | YOKNEAM ILLIT | 20692 | |
| K123860 | INMODE MD LTD. |
20 HATA'AS STR., SUITE 102 | KFAR SABA | 44425 | |
| K092326 | JEISYS MEDICAL, INC. |
5401 S. COTTONWOOD CT. | GREENWOOD VILLAGE | CO | 80121 |
| K212907 | Kam Yuen Plastic Products Ltd. |
No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town | ZhongShan | 518100 | |
| K193072 | LUVO Medical Technologies, Inc. |
125 Fleming Dr | Cambridge | N1T 2B8 | |
| K100053 | MATTIOLI ENGINEERING CORP. |
8300 GREENSBORO DR. | MCLEAN | VA | 22102 |
| K111350 | MEDICAM INC. |
7900 JEAN-BRILLON | MONTREAL, QUEBEC | H8N 2L5 | |
| K192521 | Shangdong Huamei Technology Co., Ltd. |
No. 588, Changning Street, High-tech District | Weifang | 261205 | |
| K230816 | Shangdong Huamei Technology Co., Ltd. |
No. 588, Changning Street, High-tech District, | Weifang | 261205 | |
| K093627 | SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD. |
49 CANDLEWOOD WAY | BUENA PARK | CA | 90621 |
| K200746 | Shanghai Apolo Medical Technology Co., Ltd. |
4F, Building A, No.388, Yindu Road, Xuhui District | Shanghai | 200231 | |
| K220214 | Shanghai Omni Laser Skinology Co., Ltd. |
Floor 3, Building 3, NO.227, Mingqiang Road, | Shanghai | 201612 | |
| K140631 | SHASER, INC. |
10 Maguire Rd Ste 120 | Lexington | MA | 02421 |
| K120080 | SHASER, INC. |
32 HARRISON ST. | MELROSE | MA | 02176 |
| K132266 | SHASER, INC. |
10 MAGUIRE RD STE 120 | LEXINGTON | MA | 02421 |
| K103560 | SHASER, INC. |
32 HARRISON ST. | MELROSE | MA | 02176 |
| K141583 | SHASER, INC. |
10 Maguire Rd Ste 120 | Lexington | MA | 02421 |
| K150282 | SHASER, INC. |
10 MAGUIRE ROAD | LEXINGTON | MA | 02421 |
| K133201 | SHASER, INC. |
10 MAGUIRE RD | LEXINGTON | MA | 02421 |
| K130015 | SHASER, INC. |
10 MAGUIRE RD STE 120 | LEXINGTON | MA | 02421 |
| K132170 | SHASER, INC. |
10 MAGUIRE ROAD | LEXINGTON | MA | 02421 |
| K212099 | Shenzhen Accompany Technology Co., Ltd. |
Unit. 375, Xiangnan Ruifeng Gradan, No. 22, Guimiao Road, | Shenzhen | ||
| K210119 | Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd |
RM202-203, Y2 Building, Chuangyi Park, Bantian Town, | Shenzhen | ||
| K091664 | SHENZHEN GSD TECH. CO., LTD. |
SUITE 8D, NO.19, LANE 999 | SHANGHAI | 200030 | |
| K221214 | Shenzhen IONKA Medical Technology Co., Ltd. |
Room 601, No. 3, Jiazitang Second Industrial Zone, | Shenzhen | 518123 | |
| K211368 | Shenzhen Mywin Technology Co., Ltd. |
2nd Floor, Building B, New Age gongrong Industrial Zone, | Shenzhen | ||
| K231394 | Smedtrum Medical Technology Co., Ltd. |
1F., No. 8, Ln. 97, Wugong Rd., | New Taipei City | 248016 | |
| K121515 | SOLTA MEDICAL, INC. |
25881 INDUSTRIAL BLVD | HAYWARD | CA | 94545 |
| K161565 | STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD |
10-11th Floor, Bensi Building, New High-Tech-Park, | Shenzhen | ||
| K123845 | SYNERON BEAUTY LTD. |
1835 MARKET ST., 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K131649 | SYNERON BEAUTY LTD. |
1835 MARKET ST., 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K121598 | SYNERON MEDICAL LTD. |
1835 MARKET ST, 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K220794 | Tentech Co. Ltd. |
3F Hyungkyung Building, 611, Seolleung-ro | Gangnam-gu | 06103 | |
| K123889 | THERAVANT CORPORATION |
131 Kelekent Lane | Cary | NC | 27518 |
| K213558 | Ulike Co., Ltd |
2, Myeongdong, 6-gil, Jung-gu | Seoul | ||
| K232192 | Venus Concept Inc. |
1800 Bering Drive | San Jose | CA | 95112 |
| K152790 | VENUS CONCEPT LTD. |
4556 N. HIATUS ROAD | SUNRISE | FL | 33351 |
| K153717 | Venus Concept Ltd. |
4556 N. Hiatus Road | Sunrise | FL | 33351 |
| K090399 | VIORA LTD. |
30 MONTGOMERY STREET | JERSEY CITY | NJ | 07302 |
| K131712 | YBK INVESTMENT INC. |
1915 WHITE STAR DR. | DIAMOND BAR | CA | 91765 |
| K090724 | YPERION TECHNOLOGY |
2 RUE BEETHOVEN | PARIS | 75016 |
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