FDA 510(k) Applications for Medical Device:
Powered Laser Surgical Instrument With Microbeam\Fractional Output
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K221268 | AVAVA, Inc |
275 Second Avenue, Floor 3 | Waltham | MA | 02451 |
| K223871 | Avava, Inc. |
275 Second Avenue, Floor 3 | Waltham | MA | 02451 |
| K202884 | AVAVA, Inc. |
275 Second Avenue, Floor 3 | Waltham | MA | 02451 |
| K162398 | BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. |
ROOM 305, NO.43, XIZHIMEN NORTH STREET, HAIDIAN DISTRICT | BEIJING | 100044 | |
| K111831 | BIO-MED U.S.A., INC. |
111 ELLISON ST. | PATERSON | NJ | 07505 |
| K131903 | ECLIPSE AESTHETICS, LLC |
13988 Diplomat Dr Suite 160 | Dallas | TX | 75234 |
| K100487 | ECLIPSEMED GLOBAL, INC |
16850 DALLAS PARKWAY | DALLAS | TX | 75248 |
| K110333 | FOCUS MEDICAL, LLC. |
23 FRANCIS J. CLARKE CIRCLE | BETHEL | CT | 06801 |
| K180036 | IDS, LTD. |
105, Byoksan Digital Valley 3 cha, Digital-ro, Guro-gu | Seoul | 08381 | |
| K182498 | Jiangsu Unimed Laser Technology Co., Ltd. |
2F, Building D4, No.6, West Dongsheng Road, | Jiangyin | 214000 | |
| K100590 | JM SYSTEM CO., LTD. |
410 DAERUNG TECHNO TOWN | GEUMCHEN-GU, SEOUL, | 153-77 | |
| K110984 | LASERING S.R.L. |
2246 CAMINO RAMON | SAN RAMON | CA | 94583 |
| K130028 | LUMENIS, LTD. |
31 HAAVODA ST. | BINYAMINA | 30500 | |
| K100610 | LUTRONIC CORPORATION |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K111840 | PALOMAR MEDICAL PRODUCTS, INC. |
82 CAMBRIDGE ST. | BURLINGTON | MA | 01803 |
| K090525 | PALOMAR MEDICAL PRODUCTS, INC. |
82 CAMBRIDGE ST. | BURLINGTON | MA | 01803 |
| K091446 | PALOMAR MEDICAL PRODUCTS, INC. |
82 CAMBRIDGE ST. | BURLINGTON | MA | 01803 |
| K101506 | PALOMAR MEDICAL TECHNOLOGIES, INC. |
15 Network Drive | Burlington | MA | 01803 |
| K103664 | PALOMAR MEDICAL TECHNOLOGIES, INC. |
15 Network Drive | Burlington | MA | 01803 |
| K213332 | Paradigm Medical Corporation |
7371 Los Brazos | San Diego | CA | 92127 |
| K090639 | QUANTEL DERMA GMBH |
601 HAGGERTY LN. | BOZEMAN | MT | 59715 |
| K221770 | Shanghai Apolo Medical Technology Co., Ltd. |
| Shanghai | 200231 | |
| K120433 | SOLTA MEDICAL, INC. |
25881 INDUSTRIAL BLVD | HAYWARD | CA | 94545 |
| K110349 | SOLTA MEDICAL, INC. |
25881 INDUSTRIAL BLVD. | HAYWARD | CA | 94545 |
| K091420 | SOLTA MEDICAL, INC. |
25881 INDUSTRIAL BLVD. | HAYWOOD | CA | 94043-2991 |
| K141046 | SRMC CO., LTD |
2651 E CHAPMAN AVE. SUITE 110 | FULLERTON | CA | 92831 |
| K101490 | THERMAGE, INC. |
25881 INDUSTRIAL BLVD. | HAYWARD | CA | 94545 |
| K130459 | TRIA BEAUTY, INC. |
555 13TH STREET, NW | WASHINGTON | DC | 20004 |
| K141868 | TRIA BEAUTY, INC. |
555 THIRTEENTH ST NW | WASHINGTON | DC | 20004 |
| K192350 | Wingderm Electro-Optics Ltd. |
Rm 312, Building D-3, Dongsheng Science Park, | Beijing | 100192 |
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