The following data is part of a premarket notification filed by Vsi Co., Ltd. with the FDA for Clarox.
| Device ID | K221286 |
| 510k Number | K221286 |
| Device Name: | CLAROX |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | VSI Co., Ltd. 151-33, Namseok-ro Nami-myeon, Seowon-gu Cheongju-si, KR 28182 |
| Contact | Jake Yu |
| Correspondent | Edward Park LightenBridge LLC 4408 Tortuga Ln McKinney, TX 75070 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-03 |
| Decision Date | 2022-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800124900007 | K221286 | 000 |