The following data is part of a premarket notification filed by Induction Therapies Llc with the FDA for Collagen P.i.n. (percutaneous Induction Needling).
| Device ID | K222199 |
| 510k Number | K222199 |
| Device Name: | Collagen P.I.N. (Percutaneous Induction Needling) |
| Classification | Powered Microneedle Device |
| Applicant | Induction Therapies LLC 1920 Stanley Gault Parkway, Suite 100 Louisville, KY 40223 |
| Contact | Amelia Aslam |
| Correspondent | Laurie A. Clarke Technology Sciences Group, Inc. 1150 18th Street NW, Suite 475 Washington, DC 20036 |
| Product Code | QAI |
| CFR Regulation Number | 878.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-22 |
| Decision Date | 2022-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00196852959570 | K222199 | 000 |
| 00196852440313 | K222199 | 000 |
| 00850021673024 | K222199 | 000 |
| 00850021673017 | K222199 | 000 |
| 00850021673031 | K222199 | 000 |
| 00850021673048 | K222199 | 000 |
| 00850021673062 | K222199 | 000 |
| 00850021673055 | K222199 | 000 |
| 00850021673079 | K222199 | 000 |