The following data is part of a premarket notification filed by Sebacia, Inc. with the FDA for Sebacia Microparticles.
| Device ID | K181518 |
| 510k Number | K181518 |
| Device Name: | Sebacia Microparticles |
| Classification | Laser Absorbing Particles |
| Applicant | Sebacia, Inc. 2905 Premiere Parkway, Suite 150 Duluth, GA 30097 |
| Contact | Todd J. Meyer |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 13th St. NW Washington, DC 20004 |
| Product Code | QCY |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-08 |
| Decision Date | 2018-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850002391019 | K181518 | 000 |
| G256SEB2503PUS1 | K181518 | 000 |