The following data is part of a premarket notification filed by Lerner Medical Devices, Inc. with the FDA for Lh-75 Phototherapy System.
| Device ID | K091568 |
| 510k Number | K091568 |
| Device Name: | LH-75 PHOTOTHERAPY SYSTEM |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | LERNER MEDICAL DEVICES, INC. 1545 SAWTELLE BLVD., SUITE 36 Los Angeles, CA 90025 |
| Contact | Zafirios F Gourgouliatos |
| Correspondent | Zafirios F Gourgouliatos LERNER MEDICAL DEVICES, INC. 1545 SAWTELLE BLVD., SUITE 36 Los Angeles, CA 90025 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-02 |
| Decision Date | 2009-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B280A0003000 | K091568 | 000 |