510(k) K181518
K181518 is an FDA 510(k) premarket notification submitted by Sebacia, Inc. for the device "Sebacia Microparticles". The FDA issued a decision of Substantially Equivalent on September 6, 2018. The device falls under product code QCY (Laser Absorbing Particles), a Class II device regulated under 21 CFR 878.4810.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2018
- Date Received
- June 8, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser Absorbing Particles
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy.