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 |