LED Eye Perfector, model: EY-36A, EY-36B
FDA 510(k) K221444 · Light Tree Ventures Europe B.V.
510(k) numberK221444
Submission
- Device name
- LED Eye Perfector, model: EY-36A, EY-36B
- Applicant
- Light Tree Ventures Europe B.V.
Den Haag, NL - Received
- May 18, 2022
- Decision date
- December 8, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OHS – Light Based Over The Counter Wrinkle Reduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
Other 510(k)s with product code OHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…OHS · Traditional | Kam Yuen Plastic Products , Ltd. | 08/31/2026SE |
| K261602 | Eye Recovery Pro (PH-e03)OHS · Traditional | Shenzhen Goodwind Technology Development Co., Ltd. | 08/10/2026SE |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)OHS · Traditional | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 08/07/2026SE |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…OHS · Traditional | Shenzhen Qianyu Technology Co., Ltd. | 08/04/2026SE |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756)OHS · Traditional | Duplex International Trading Limited | 08/04/2026SE |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038)OHS · Traditional | Led Intellectual Properties, LLC | 07/31/2026SE |
| K260598 | 5 Wavelength LED Facemask (TN2508)OHS · Traditional | iSMART Developments, Ltd. | 07/24/2026SE |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…OHS · Traditional | Dongguan Miqiang Technology Co., Ltd. | 07/15/2026SE |
| K261473 | ChromixOHS · Traditional | Termosalud S.L. | 07/01/2026SE |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)OHS · Traditional | Guangdong Newdermo Biotech Co., Ltd. | 06/29/2026SE |
More from Guangdong Newdermo Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260415 | myLEDmask 2 (MJ-144)OHS · Traditional | 05/12/2026SE |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC)OAP · Traditional | 12/24/2025SE |
| K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001OLP · Traditional | 07/03/2023SE |
| K223893 | Infrared Heat (Model: E0221)OHS · Traditional | 05/16/2023SE |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)OAP · Traditional | 04/28/2023SE |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023)OHS · Traditional | 04/28/2023SE |
| K230336 | CurrentBody Skin Led Hair Regrowth(Model: MZ-07)OAP · Traditional | 04/05/2023SE |
| K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)OHS · Traditional | 03/15/2023SE |
| K223642 | LED Lip Perfector, model: ZC-05ILY · Traditional | 03/09/2023SE |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)OHS · Traditional | 12/20/2022SE |
Questions and answers
When was LED Eye Perfector, model: EY-36A, EY-36B cleared by the FDA?
LED Eye Perfector, model: EY-36A, EY-36B (K221444) received a 510(k) decision of Substantially Equivalent on December 8, 2022, 204 days after the submission was received.
What is the product code of K221444?
The FDA product code is OHS – Light Based Over The Counter Wrinkle Reduction, a Class II (moderate risk) device regulated under 21 CFR 878.4810.