The following data is part of a premarket notification filed by Healthlight, Llc with the FDA for Healthlight Microcontroller Models Hl-fb (footbed), Hl-hb (headband) And Hl-fm (facemask) Led Light Therapy System.
| Device ID | K163079 |
| 510k Number | K163079 |
| Device Name: | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) And HL-FM (Facemask) LED Light Therapy System |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | HealthLight, LLC 920 East State Parkway, Suite B Schaumburg, IL 60173 |
| Contact | Warren Graber |
| Correspondent | Alexander Braun Henderson HealthLight, LLC 920 East State Parkway, Suite B Schaumburg, IL 60173 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-03 |
| Decision Date | 2017-06-13 |