The following data is part of a premarket notification filed by Light Tree Ventures Europe B.v. with the FDA for Cold Sore Device (model: Qpz-01).
| Device ID | K222205 |
| 510k Number | K222205 |
| Device Name: | Cold Sore Device (Model: QPZ-01) |
| Classification | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 |
| Applicant | Light Tree Ventures Europe B.V. Laan Van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague, NL |
| Contact | Alain Dijkstra |
| Correspondent | Alain Dijkstra Light Tree Ventures Europe B.V. Laan Van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague, NL |
| Product Code | OKJ |
| CFR Regulation Number | 878.4860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-25 |
| Decision Date | 2022-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10031191713032 | K222205 | 000 |