Dynatron X3 , Dynatron XP Ir Light Pad, D405 Ir Light Probe
FDA 510(k) K051261 · Dynatronics Corp.
510(k) numberK051261
Submission
- Device name
- Dynatron X3 , Dynatron XP Ir Light Pad, D405 Ir Light Probe
- Applicant
- Dynatronics Corp.
Salt Lake City, UT, US - Received
- May 16, 2005
- Decision date
- July 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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| K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…IMI · Traditional | 10/22/2003SE |
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Questions and answers
When was Dynatron X3 , Dynatron XP Ir Light Pad, D405 Ir Light Probe cleared by the FDA?
Dynatron X3 , Dynatron XP Ir Light Pad, D405 Ir Light Probe (K051261) received a 510(k) decision of Substantially Equivalent on July 25, 2005, 70 days after the submission was received.
What is the product code of K051261?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.