MEDICAL QUANT USA
Registration 3005730446FEI 3005730446Solon, OH
Owner/operator: Multi Radiance Medical
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 13
- Added, last 12 months
- 3
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 13
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| ILY | Contoura Laser StimLamp, Infrared, Therapeutic Heating | Class 2 | 21 CFR 890.5500 | K071445 |
| ILY | TQ LaserLamp, Infrared, Therapeutic Heating | Class 2 | 21 CFR 890.5500 | K061614 |
| ILY | HOLISTIC BODY SHOP RELIEF+Lamp, Infrared, Therapeutic Heating | Class 2 | 21 CFR 890.5500 | — |
| ILY | LS50 EmitterLamp, Infrared, Therapeutic Heating | Class 2 | 21 CFR 890.5500 | K080102 |
| IRP | Force-X CX5Massager, Powered Inflatable TubeAdded Jul 20, 2026 | Class 2 | 21 CFR 890.5650 | K253919 |
| ILO | Force-X CX5Pack, Hot Or Cold, Water CirculatingAdded Jul 20, 2026 | Class 2 | 21 CFR 890.5720 | K253919 |
| GEX | TQ LaserPowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K061614 |
| GEX | Contoura Laser StimPowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K071445 |
| GEX | LS50 EmitterPowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K080102 |
| NHN | MR5 Activ ProPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain TherapyAdded Jun 2, 2026 | Class 2 | 21 CFR 890.5500 | K254024 |
| NHN | FibroluxPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | Class 2 | 21 CFR 890.5500 | K212189 |
| NHN | MR4 LaserPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | Class 2 | 21 CFR 890.5500 | K171354 |
and 1 more on your full dossier
What changed
- Jul 20, 2026Listing added: IRP — Force-X CX5 (K253919)
- Jul 20, 2026Listing added: ILO — Force-X CX5 (K253919)
- Jun 2, 2026Listing added: NHN — MR5 Activ Pro (K254024)