The following data is part of a premarket notification filed by Quantum Devices, Inc. with the FDA for Quantum Warp 10 Light Delivery System.
| Device ID | K032229 |
| 510k Number | K032229 |
| Device Name: | QUANTUM WARP 10 LIGHT DELIVERY SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | QUANTUM DEVICES, INC. PO BOX 848 Grayslake, IL 60030 |
| Contact | Michele H Vovolka |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-09-12 |
| Summary: | summary |