The following data is part of a premarket notification filed by Quantum Skincare, Inc. with the FDA for Quasar, Model Md21.
| Device ID | K032379 |
| 510k Number | K032379 |
| Device Name: | QUASAR, MODEL MD21 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | QUANTUM SKINCARE, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss QUANTUM SKINCARE, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-01 |
| Decision Date | 2003-11-20 |
| Summary: | summary |