FDA 510(k) Applications for Medical Device:
Laser, Dental, Soft Tissue
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K210350 | Azena Medical, LLC |
3021 Citrus Circle Suite 180 | Walnut Creek | CA | 94598 |
| K213428 | Biolase Inc. |
27042 Towne Centre Drive, Suite 270 | Foothill Ranch | CA | 92610 |
| K221761 | Convergent Dental, Inc. |
140 Kendrick Street | Needham | MA | 02494 |
| K201387 | DentLight Inc. |
1825 Summit Ave. Ste 210 | Plano | TX | 75074 |
| K213658 | El.En Electronic Engineering Spa |
Via Baldanzese 17 | Calenzano | FL | 50041 |
| K203396 | El.En. Electronic Engineering Spa |
Via Baldanzese 17 | Calenzano | 50041 | |
| K230047 | Gigaalaser Company Ltd. |
304, 306, 3F No.3 plant, Building B10 | Wuhan | 430206 | |
| K210367 | Guilin Woodpecker Medical Instrument Co., Ltd. |
Information Industrial Park, Guilin National High-Tech Zone | Guilin | 541004 | |
| K030146 | KAVO AMERICA |
340 EAST MAIN ST. | LAKE ZURICH | IL | 60047 |
| K232222 | Medency S.r.l. |
Via degli Ontani, 48 | Vicenza | 36100 | |
| K232885 | Shanghai Wonderful Opto-Electrics Tech Co., Ltd. |
2F, Building 11, Lane 1175, Tongpu Rd., Putuo District | Shanghai | 200333 | |
| K214008 | Shenzhen Soga Technology Co., Ltd. |
D906, Yinxing Technology Building No. 1301, Sightseeing Road | Shenzhen | 518110 | |
| K211150 | Shenzhen Soga Technology Co., Ltd. |
D906, Yinxing Technology Building No. 1301, Sightseeing | Shenzhen | 518110 | |
| K243764 | Wuhan Pioon Technology Co., Ltd. |
12th Fl, Bldg 1, Innovative Unit, R&D Center Project,Marine | Wuhan | 430205 |
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