The following data is part of a premarket notification filed by Ulthera, Inc. with the FDA for Ulthera System.
| Device ID | K122528 |
| 510k Number | K122528 |
| Device Name: | ULTHERA SYSTEM |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | ULTHERA, INC. 1840 S Stapley Dr Suite 200 Mesa, AZ 85204 |
| Contact | Suzon Lommel |
| Correspondent | Suzon Lommel ULTHERA, INC. 1840 S Stapley Dr Suite 200 Mesa, AZ 85204 |
| Product Code | OHV |
| CFR Regulation Number | 878.4590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-20 |
| Decision Date | 2012-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840763100292 | K122528 | 000 |
| 00840763100285 | K122528 | 000 |
| 00840763100278 | K122528 | 000 |
| 00840763100209 | K122528 | 000 |
| 00840763100193 | K122528 | 000 |
| 00840763100186 | K122528 | 000 |
| 00840763100179 | K122528 | 000 |
| 00840763100162 | K122528 | 000 |
| 00840763100155 | K122528 | 000 |