The following data is part of a premarket notification filed by Genesis Health Light Corporation with the FDA for Cs1000 Light Therapy Device.
| Device ID | K110558 |
| 510k Number | K110558 |
| Device Name: | CS1000 LIGHT THERAPY DEVICE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | GENESIS HEALTH LIGHT CORPORATION 7 INNOVATION DRIVE SUITE 102 Hamilton, Ontario, CA L9h 7h9 |
| Contact | Paul Ziemer |
| Correspondent | Paul Ziemer GENESIS HEALTH LIGHT CORPORATION 7 INNOVATION DRIVE SUITE 102 Hamilton, Ontario, CA L9h 7h9 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-28 |
| Decision Date | 2012-07-12 |
| Summary: | summary |