The following data is part of a premarket notification filed by Lerner Medical Devices, Inc. with the FDA for Levia Phototherapy System.
Device ID | K040062 |
510k Number | K040062 |
Device Name: | LEVIA PHOTOTHERAPY SYSTEM |
Classification | Light, Ultraviolet, Dermatological |
Applicant | LERNER MEDICAL DEVICES, INC. 1545 SAWTELLE BLVD., SUITE 36 Los Angeles, CA 90025 |
Contact | Zafirios Gourgouliatos |
Correspondent | N.e. Devine, Jr. ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-01-13 |
Decision Date | 2004-02-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B280951CTLS0 | K040062 | 000 |
B2809951CTLS220 | K040062 | 000 |