FDA 510(k) Applications for Medical Device:
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K231628 | BeShape Technologies Ltd. |
23 Hatas St. | Kfar-Saba | 4442525 | |
| K230100 | Classys Inc |
Classys, 208, Teheran-ro, Gangnam-gu | Seoul | 06221 | |
| K181896 | Jeisys Medical, Inc. |
307, Daeryung Techno Town 8th, | Seoul | 153-775 | |
| K100874 | MEDICIS TECHNOLOGIES CORPORATION |
COLUMBIA SQUARE | WASHINGTON | DC | 20004 |
| K112626 | MEDICIS TECHNOLOGIES CORPORATION |
11818 NORTH CREEK PARKWAY N. | BOTHELL | WA | 98011 |
| K230820 | Sofwave Medical Ltd |
1 Ha-Otsma St., | Yokneam Illit | 2069200 / | |
| K191421 | Sofwave Medical Ltd. |
Beit Tavor 2 | Yokneam | ||
| K240687 | Sofwave Medical Ltd. |
1 Ha-Otsma St. | Yokneam IIit | 2069200 | |
| K223237 | Sofwave Medical Ltd. |
1 Ha-Otsma St. | Yokneam Ilit | 2069200 | |
| K230019 | Sofwave Medical Ltd. |
1 Ha-Otsma St. | Yokneam Ilit | 2069200 | |
| K231537 | Sofwave Medical Ltd. |
1 Ha-Otsma St. | Yokneam Ilit | 2069200 | |
| K232455 | Sofwave Medical Ltd. |
1 Ha-Otsma St. | Yokneam Ilit | 2069200 | |
| K233104 | Sofwave Medical Ltd. |
1 Ha-Otsma St. | Yokneam llit | 2069200 | |
| K211483 | Sofwave Medical Ltd. |
Beit Tavor 2 | Yokneam Ilit | 2069202 | |
| K133238 | SYNERON MEDICAL LTD |
1835 MARKET ST, 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K160896 | SYNERON MEDICAL LTD |
TAVOR BUILDING, INDUSTRIAL ZONE, P.O.B.550 | Yokneam Illit | 20692 | |
| K162163 | SYNERON MEDICAL LTD |
TAVOR BUILDING, INDUSTRIAL ZONE, P.O.B. 550 | Yokneam Illit | 20692 | |
| K170370 | Syneron Medical Ltd. |
Tavor Building, Industrial Zone, P.O.B. 550 | Yokneam Illit | 20692 | |
| K141708 | SYNERON MEDICAL LTD. |
1835 MARKET ST, 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K161952 | Syneron Medical Ltd. |
Tavor Building, Industrial Zone, P.O.B. 550 | Yokneam Illit | 20692 | |
| K250418 | Ulthera Inc. |
6501 Six Forks Road | Raleigh | NC | 27615 |
| K180623 | Ulthera, Inc |
1840 South Stapley Drive Suite 200 | Mesa | AZ | 85204 |
| K121700 | ULTHERA, INC. |
1840 S Stapley Dr Suite 200 | Mesa | AZ | 85204 |
| K122528 | ULTHERA, INC. |
1840 S Stapley Dr Suite 200 | Mesa | AZ | 85204 |
| K132028 | ULTHERA, INC. |
2150 S. Country Club Drive | Mesa | AZ | 85210 |
| K134032 | ULTHERA, INC. |
2150 S. Country Club Drive | Mesa | AZ | 85210 |
| K233996 | Ulthera, Inc. |
1840 S. Stapley Dr. | Mesa | AZ | 85204 |
| DEN080006 | ULTHERA, INC. |
33 SOUTH SYCAMORE STREET | MESA | AZ | 85202 |
| K243035 | Ulthera, Inc. |
6501 Six Forks Road | Raleigh | NC | 27615 |
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