The following data is part of a premarket notification filed by Ptech Co., Ltd. with the FDA for Paintb, Paintj.
| Device ID | K203337 |
| 510k Number | K203337 |
| Device Name: | PainTB, PainTJ |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | Ptech Co., Ltd. 35, Wondogok-gil, Poseung-eup Pyeongtaek-si, KR 13449 |
| Contact | Yosung Choi |
| Correspondent | Yosung Choi Ptech Co., Ltd. 35, Wondogok-gil, Poseung-eup Pyeongtaek-si, KR 13449 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2022-02-11 |