The following data is part of a premarket notification filed by Biosonic Technologies, Llc with the FDA for Beautiful Image Facial Sculpting Device.
| Device ID | K130065 |
| 510k Number | K130065 |
| Device Name: | BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | BIOSONIC TECHNOLOGIES, LLC 28241 CROWN VALLEY PARKWAY SUITE 510(K) Laguna Niguel, CA 92677 |
| Contact | Shepard G Bentley |
| Correspondent | Shepard G Bentley BIOSONIC TECHNOLOGIES, LLC 28241 CROWN VALLEY PARKWAY SUITE 510(K) Laguna Niguel, CA 92677 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-10 |
| Decision Date | 2014-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860558000422 | K130065 | 000 |