WARP10, WARP75

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K113231 ↗

FDA Product Code

ILY

Device Class

Class II

Regulation

21 CFR Part 890.5500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Quantum Warp 10 Light Delivery System

  Class II

  FDA 510(k) K032229 Active Cleared 12 Sep 2003

• What are the primary clinical applications for the Warp10 and Warp75 devices, and how do they work?

  The Warp10 and Warp75 are designed for photobiomodulation therapy, a technique using near-infrared light to stimulate cellular repair and tissue regeneration. Clinically, they are primarily used in physical medicine applications, such as accelerating wound healing, reducing inflammation, or aiding muscle recovery. The devices emit near-infrared energy via solid-state LED technology, delivering consistent, targeted light output to promote therapeutic effects.

• Are the Warp10 and Warp75 single-use or reusable, and what does that mean for clinical workflows?

  The Warp10 and Warp75 are reusable medical instruments, meaning they are intended for repeated use across multiple patients. This design allows for greater cost efficiency in clinical settings, though proper cleaning and maintenance protocols must be followed to ensure safety and performance. Unlike single-use devices, they require institutional policies for reprocessing and sterilization (if applicable) to prevent cross-contamination.

• What distinguishes the Warp10 model from the Warp75 model, and how might that affect treatment decisions?

  The distinction between the Warp10 and Warp75 lies in their designated output or application focus, though specific technical differences (e.g., wattage, wavelength, or treatment area coverage) are not detailed in the provided data. Clinically, the choice may depend on factors like treatment site size, patient needs, or clinician preference for portability. Both are hand-held and portable, but the numerical difference suggests potential variations in therapeutic output or application versatility.

• How were the Warp10 and Warp75 approved by the FDA, and what does that mean for their use in clinical settings?

  The Warp10 and Warp75 received FDA 510(k) clearance (K113231), which means they were determined to be substantially equivalent to a legally marketed device already on the market. This classification falls under the Physical Medicine advisory committee, indicating their primary regulatory focus is on therapeutic applications in musculoskeletal or soft tissue recovery. Clinically, this approval pathway ensures they meet FDA safety and effectiveness standards for their intended use.

• Do the Warp10 and Warp75 have any special storage or handling requirements, particularly regarding environmental conditions?

  The provided data does not specify explicit storage requirements beyond their classification as reusable medical instruments. However, as near-infrared light therapy devices, they should be stored in a clean, dry environment protected from extreme temperatures or humidity to preserve LED integrity and performance. Since they are not labeled as sterile, clinical settings should follow standard disinfection protocols for reusable devices before and after use.