The following data is part of a premarket notification filed by Ulthera, Inc. with the FDA for Ulthera System.
| Device ID | K134032 |
| 510k Number | K134032 |
| Device Name: | ULTHERA SYSTEM |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | ULTHERA, INC. 2150 S. Country Club Drive Suite 21 Mesa, AZ 85210 |
| Contact | Ashley Fickett |
| Correspondent | Ashley Fickett ULTHERA, INC. 2150 S. Country Club Drive Suite 21 Mesa, AZ 85210 |
| Product Code | OHV |
| CFR Regulation Number | 878.4590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2014-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840763100919 | K134032 | 000 |
| 00840763100322 | K134032 | 000 |
| 00840763100315 | K134032 | 000 |
| 00840763100308 | K134032 | 000 |
| 00840763100254 | K134032 | 000 |
| 00840763100247 | K134032 | 000 |
| 00840763100230 | K134032 | 000 |
| 00840763100223 | K134032 | 000 |
| 00840763100216 | K134032 | 000 |
| 00840763100070 | K134032 | 000 |
| 00840763100063 | K134032 | 000 |
| 00840763100056 | K134032 | 000 |
| 00840763100049 | K134032 | 000 |
| 00840763100339 | K134032 | 000 |
| 00840763100346 | K134032 | 000 |
| 00840763100902 | K134032 | 000 |
| 00840763100896 | K134032 | 000 |
| 00840763100889 | K134032 | 000 |
| 00840763100865 | K134032 | 000 |
| 00840763100858 | K134032 | 000 |
| 00840763100841 | K134032 | 000 |
| 00840763100834 | K134032 | 000 |
| 00840763100506 | K134032 | 000 |
| 00840763100490 | K134032 | 000 |
| 00840763100438 | K134032 | 000 |
| 00840763100421 | K134032 | 000 |
| 00840763100353 | K134032 | 000 |
| 00840763100025 | K134032 | 000 |