The following data is part of a premarket notification filed by Good Doctors Co.,ltd. with the FDA for Ic-whcd100 (inspire).
| Device ID | K183471 |
| 510k Number | K183471 |
| Device Name: | IC-WHCD100 (Inspire) |
| Classification | Laser, Fluorescence Caries Detection |
| 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. 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-14 |
| Decision Date | 2020-07-02 |