The following data is part of a premarket notification filed by Lg Electronics, Inc. with the FDA for Lg Pra. L Derma Ld Scalp Care.
Device ID | K200464 |
510k Number | K200464 |
Device Name: | LG Pra. L Derma LD Scalp Care |
Classification | Laser, Comb, Hair |
Applicant | LG Electronics, Inc. 222 LG-ro Jinwi-myeon Pyeongtaek-si, KR 17709 |
Contact | Eunmi Ji |
Correspondent | Do-hyun Kim BT Solutions, Inc. 904-ho, Eonju-ro 86-gil 5 Gangnam-gu Seoul, KR 06210 |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-02-26 |
Decision Date | 2020-07-23 |