LightStim for Pain LED Belt
FDA 510(k) K151333 · Led Intellectual Properties, LLC
510(k) numberK151333
Submission
- Device name
- LightStim for Pain LED Belt
- Applicant
- Led Intellectual Properties, LLC
Irvine, CA, US - Received
- May 19, 2015
- Decision date
- August 21, 2015
- 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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Questions and answers
When was LightStim for Pain LED Belt cleared by the FDA?
LightStim for Pain LED Belt (K151333) received a 510(k) decision of Substantially Equivalent on August 21, 2015, 94 days after the submission was received.
What is the product code of K151333?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.