Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301
FDA 510(k) K083580 · Led Intellectual Properties, LLC
510(k) numberK083580
Submission
- Device name
- Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301
- Applicant
- Led Intellectual Properties, LLC
Knoxville, TN, US - Received
- December 3, 2008
- Decision date
- June 22, 2009
- 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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More from Wellray Medical Laser, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038)OHS · Traditional | 07/31/2026SE |
| K212771 | LightStim ElipsaOHS · Traditional | 01/26/2022SE |
| K153399 | LightStim Professional LED BedILY · Traditional | 07/05/2016SE |
| K151336 | LightStim Professional 2-Panel LightOHS · Traditional | 10/23/2015SE |
| K151333 | LightStim for Pain LED BeltILY · Traditional | 08/21/2015SE |
| K150098 | LightStim Professional 2-Panel LightOHS · Traditional | 04/09/2015SE |
| K142246 | LightStim for Acne/ LightStim for Acne MiniOLP · Traditional | 01/29/2015SE |
| K131461 | Lightstim for Acne/ Lightstim for Acne MiniOLP · Traditional | 01/06/2014SE |
| K120775 | Light for WrinklesOHS · Traditional | 06/04/2012SE |
| K101190 | Lightstim Anti-Wrinkle OTC Model Aal OTCOHS · Traditional | 07/01/2010SE |
Questions and answers
When was Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301 cleared by the FDA?
Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301 (K083580) received a 510(k) decision of Substantially Equivalent on June 22, 2009, 201 days after the submission was received.
What is the product code of K083580?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.