510(k) K221444
- Device
- LED Eye Perfector, Model: EY-36A, EY-36B
- Applicant
- Light Tree Ventures Europe B.V.
- 510(k) number
- K221444
- Product code
- OHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-08
- Date received
- 2022-05-18
- Regulation
- 878.4810
- Classification name
- Light Based Over The Counter Wrinkle Reduction
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kim Laurens
- Address
- Laan Van Ypenburg 108 Den Haag NL 2497 GC 2497 GC
FDA Registration Numbers#
- 3013738756
- 3010027944
- 3014737458
- 3015924074
- 3035785623
- 3030234143
- 3013481783
- 3042261413
- 3017649333
- 3014386328
- 3042131929
- 3033850489
- 3019887520
- 3010724743
- 3010402752
- 3027645761
- 3039304811
- 3031595583
- 3009102830
- 3008345424
- 3004450661
- 3038214786
- 3015287734
- 3007689716
- 3012294783
- 1222304
- 3013178978
- 3019577501
- 3024892917
- 3015109022
- 3027651556
- 3018994966
- 3042970900
- 3023339107
- 3017555752
- 3008929787
- 3016879560
- 3023339103
- 3033435469
- 3004126239
- 3030194742
- 3011721071
- 3043749884
- 3048610148
- 3008592814
- 3017619615
- 3012470925
- 3022426824
- 3015974280
- 3038319732
- 3039443706
- 3033847811
- 3004167969
- 3016055197
- 3019864920
- 3011564440
- 3015289316
- 1318319
- 3007744197
- 3015168585
- 3021599225
- 3015619973
- 3017140525
- 3007554929
- 3012327767
- 3015646995
- 3037031835
- 3017382141
- 3020659203
- 3025309920
- 3012657194
- 3016076077
- 3017618922
- 3042254846
- 3013689783
- 3007238544
- 3012113199
- 3023371360
- 3012386142
Source Documents#
Other 510(k) Records For Product Code OHS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262984 | Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02) | Shenzhen Bway Tech Co., Ltd. | 2026-10-26 |
| K262752 | Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | 2026-10-23 |
| K262932 | AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) | Shenzhen Accompany Technology Co., Ltd. | 2026-10-19 |
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | Kam Yuen Plastic Products , Ltd. | 2026-08-31 |
| K261602 | Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. | 2026-08-10 |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-08-07 |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | 2026-08-04 |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) | Shenzhen Qianyu Technology Co., Ltd. | 2026-08-04 |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC | 2026-07-31 |
| K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | 2026-07-24 |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) | Dongguan Miqiang Technology Co., Ltd. | 2026-07-15 |
| K261473 | Chromix | Termosalud S.L. | 2026-07-01 |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-29 |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-18 |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-06-16 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases