DIOWAVE LOW LEVEL COLD LASER SYSTEM
FDA 510(k) clearance K121363 · decided 2012-11-23
Clearance details
- K-number
- K121363
- Device name
- DIOWAVE LOW LEVEL COLD LASER SYSTEM
- Applicant
- Technological Medical Advancments, Inc. (Tma)
- Decision
- Substantially Equivalent
- Date received
- 2012-05-07
- Decision date
- 2012-11-23
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- West Palm Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Diowave Laser System, REF: Diowave 250W recall (Z-2162-2026) | Technological Medical Advancements LLC | 2026-05-11 |