The following data is part of a premarket notification filed by Cytonsys Inc with the FDA for Cytonpro-5000.
| Device ID | K213524 |
| 510k Number | K213524 |
| Device Name: | CytonPro-5000 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | Cytonsys Inc 7801 N. Lamar Blvd, Ste C-59 Austin, TX 78752 |
| Contact | Li-Da Huang |
| Correspondent | Li-Da Huang Cytonsys Inc 7801 N. Lamar Blvd, Ste C-59 Austin, TX 78752 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-03 |
| Decision Date | 2022-08-10 |