The following data is part of a premarket notification filed by Lfbeauty (thailand) Limited with the FDA for Smile Makers Personal Lubricant.
| Device ID | K182100 |
| 510k Number | K182100 |
| Device Name: | Smile Makers Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | LFBeauty (Thailand) Limited 21/7 Moo 6 Kookot Lamlukka, TH 12130 |
| Contact | Apasara Kaewlor |
| Correspondent | Shelley Shen PharmEng Technology 23 Lesmill Road North York, CA M3b 3p6 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-03 |
| Decision Date | 2019-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28859350704115 | K182100 | 000 |