The following data is part of a premarket notification filed by Good Doctors Co.,ltd. with the FDA for Dr's Light2.
| Device ID | K173157 |
| 510k Number | K173157 |
| Device Name: | Dr's Light2 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | Good Doctors Co.,Ltd. #208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu Incheon, KR 21315 |
| Contact | Sungro Joo |
| Correspondent | Priscilla Chung Lk Consulting Group USA, Inc 690 Roosevelt Irvine, CA 92620 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800025400101 | K173157 | 000 |