510(k) K202517 ยท QAI Powered Microneedle Device
Cytrellis Dermal Micro-Coring System
| Applicant | Cytrellis Biosystems, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Jul 9, 2021 |
| Received | Sep 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2023 | Cytrellis Biosystems, Inc. ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Open, Classified |
QAI | None listed |
| May 26, 2023 | Cytrellis Biosystems, Inc. Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face.
Model #: Gen 4 Completed |
QAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.