Panels › General, Plastic Surgery › Product code QAI · Class 2
Powered Microneedle Device
Regulation 878.4430
2510(k)s in 12 months (26 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in QAI
| Company | 510(k)s | Recalls |
|---|---|---|
| Cytrellis Biosystems, Inc. | 2 | 2 |
| Crown Aesthetics | 3 | 0 |
| Mt. Derm GmbH | 3 | 0 |
| Bellus Medical, LLC | 1 | 1 |
| Eclipse Medcorp, LLC | 2 | 0 |
| Esthetic Medical, Inc. | 2 | 0 |
| Su-Ko Technologies, LLC | 2 | 0 |
| Bomtech Electronics Co., Ltd. | 1 | 0 |
| Campomats S.R.L. | 1 | 0 |
| Dermalogica, LLC | 1 | 0 |
| 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 | K202517 |
| 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 | K202517 |
| Jan 18, 2019 | Bellus Medical SKINFUSE Resuce Calming Complex Kit containing:
SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a Terminated |
QAI | None listed |
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