510(k) K214101
- Device
- Project E Beauty LED Light Therapy Mask (Model: PE730)
- Applicant
- Duplex International Trading Limited
- 510(k) number
- K214101
- Product code
- OHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-23
- Date received
- 2021-12-29
- 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
- Patrick Lee
- Address
- B1, 10/F, Block 2, Golden Dragon Ind Centre, 162-170 Tai Lin Pai Rd., Kwai Chung, Nt Hong Kong CN
FDA Registration Numbers#
- 3013178978
- 3015168585
- 3012327767
- 3009102830
- 3022426824
- 3015783545
- 3012386142
- 3033847811
- 3020659203
- 3020900954
- 3042131929
- 3035785623
- 3029944286
- 3013995763
- 1318319
- 3037031835
- 3015415349
- 3006459199
- 3043749884
- 3042254846
- 3044572954
- 3019577501
- 3021282471
- 3023339107
- 3013423303
- 3004126239
- 3015603281
- 3015619973
- 3014386328
- 3027645761
- 3030541658
- 3012104022
- 3015646995
- 3037341611
- 3007744197
- 3013738756
- 1832894
- 3030234086
- 3017619615
- 3022327202
- 3048342015
- 3007554929
- 3029328624
- 3012113199
- 3015289316
- 3042261413
- 3017555752
- 3014737458
- 3021599225
- 3029972385
- 3016879560
- 3010360273
- 3016071154
- 3015313684
- 3039443706
- 3019887520
- 3036720861
- 3042970900
- 3017422691
- 3033435469
- 3013481783
- 3043710338
- 3044622318
- 3013397886
- 3007238544
- 3011644607
- 3016076077
- 3015287734
- 3016055197
- 9617486
- 3017103444
- 3010402752
- 3011564440
- 3012657194
- 3027651556
- 3043165181
- 3004839404
- 3018994966
- 3021282523
Source Documents#
Other 510(k) Records For Product Code OHS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026-06-03 |
| K260415 | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | 2026-05-12 |
| K260150 | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE | 2026-04-22 |
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