Identity
- Trade Name
- Dynatron Tri-Wave Light Probe FDA UDI
- Generic Name
- Light-energy skin surface treatment system applicator FDA UDI
- Model / Reference
- DCP3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10660584000154 FDA UDI
- 510(k) Number
- K113250 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Light-energy skin surface treatment system applicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.6 Pound FDA UDI
Category: Light-energy skin surface treatment system applicator
Dynatron Tri-Wave Light Probe by Dynatronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Light-energy skin surface treatment system applicator.
- Twain Evo — Quanta System Spa · Class II
- Twain Evo — Quanta System Spa · Class II
- Twain Evo — Quanta System Spa · Class II
- F-SR — FORMATK SYSTEMS LTD · Class II
- Twain Evo — Quanta System Spa · Class II
- Twain Evo — Quanta System Spa · Class II
- Twain Evo — Quanta System Spa · Class II
- HR690XL applicator — Venus Concept Inc. · Class II
Cleared under the same submission
K113250 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dynatronics Corp.
Sources (1)
- FDA UDI 7aafeea8-ed44-4395-b009-b04a41f09df0 36 fields · synced Jun 8, 2026