The following data is part of a premarket notification filed by Carl Zeiss Suzhou Co., Ltd. with the FDA for Fluorescence Mode.
| Device ID | K171007 |
| 510k Number | K171007 |
| Device Name: | Fluorescence Mode |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | Carl Zeiss Suzhou Co., Ltd. Modern Industrial Square 3b No. 333 Xing Pu Road Sip Suzhou, CN 215126 |
| Contact | Huang Xiaodong |
| Correspondent | Mandy Ambrecht Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-04 |
| Decision Date | 2018-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06909262100043 | K171007 | 000 |