The following data is part of a premarket notification filed by Lg Electronics, Inc. with the FDA for Lg Pra.l Derma Led Mask.
Device ID | K183671 |
510k Number | K183671 |
Device Name: | LG PRA.L DERMA LED MASK |
Classification | Light Based Over The Counter Wrinkle Reduction |
Applicant | LG Electronics, Inc. 222 LG-ro Jinwi-myeon Pyeongtaek-si, KR 17709 |
Contact | Jooyong Kim |
Correspondent | Do-hyun Kim BT Solutions, Inc. 904, Eonju-ro 86-gil 5, Seoul, KR 06210 |
Product Code | OHS |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-27 |
Decision Date | 2019-01-22 |
Summary: | summary |