The following data is part of a premarket notification filed by In Light Wellness Systems, Inc. with the FDA for Elysiom Polychromatic Led Light Therapy (pllt) System (elysiom).
| Device ID | K153389 |
| 510k Number | K153389 |
| Device Name: | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | IN LIGHT WELLNESS SYSTEMS, INC. 5601 MIDWAY PARK PLACE NE Albuquerque, NM 87109 |
| Contact | Jane Melone |
| Correspondent | Fred Ma MEDICAL QUALITY INTERNATIONAL, LLC 7195 LONGVIEW DRIVE Cleveland, OH 44139 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-03-30 |
| Summary: | summary |