510(k) K200983
- Device
- Infrared Light Therapy Led Facial Light Therapy Mask-Derma Plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine
- Applicant
- Ningbo Hesi Electric Co., Ltd
- 510(k) number
- K200983
- Product code
- OHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-07-14
- Date received
- 2020-04-14
- 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
- Ma LuLu
- Address
- #818-23-156 Qiming Rd., Yinzhou, Ningbo City Zhejiistrict, Ningbo, Zhejiang, Ningbo CN 315000 315000
FDA Registration Numbers#
- 3017140525
- 3015783545
- 3029083714
- 3014737458
- 3042970900
- 3044622318
- 1832894
- 3009765778
- 3017555752
- 3015619973
- 3035785623
- 3007744197
- 3007238544
- 3030234143
- 3030234086
- 3018949797
- 3039304811
- 3016076077
- 3015168585
- 3021282523
- 3021282471
- 3016879560
- 3010677917
- 3020659203
- 3017382141
- 3018188770
- 3015415349
- 3017422691
- 3006459199
- 3004126239
- 3018994966
- 3020900954
- 3013481783
- 3006546131
- 3015603281
- 3013689783
- 3017103444
- 3016750352
- 3015289316
- 3017649333
- 3038319732
- 3006182559
- 3016171836
- 3016055197
- 3012104022
- 3019015047
- 3019864920
- 3009102830
- 3037031835
- 3008592814
- 3027651556
- 3015313684
- 3029972385
- 3013738756
- 3013178978
- 3012512142
- 3007689716
- 3015646995
- 3012386142
- 3008929787
- 3029944286
- 3042261413
- 3027645761
- 3030220360
- 3014545271
- 3037341611
- 3019577501
- 3022327202
- 3016496662
- 3012327767
- 3033847811
- 3012657194
- 3031595583
- 1318319
- 3010360273
- 3038214786
- 3011644607
- 3011564440
- 3033793026
Source Documents#
Other 510(k) Records For Product Code OHS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026-03-23 |
| K260511 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-03-16 |
| K254079 | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | 2026-03-16 |
| K253874 | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | 2026-03-03 |
| K253683 | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | Foreo, Inc. | 2026-02-20 |
| K254007 | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&Electronic Co., Ltd. | 2026-02-12 |
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2026-01-30 |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-28 |
| K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) | Shenzhen Rainbow Technology Co., Ltd. | 2026-01-23 |
| K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | Shenzhen Saidi Light Therapy Technology Co., Ltd. | 2025-12-24 |
| K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | 2025-12-24 |
| K253135 | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) | Dongguan Yijiaming Technology Co., Ltd. | 2025-12-23 |
| K253086 | LED Light Therapy Device (Models: SG-FM, SG-FE) | Sunglor Technology Co., Ltd. | 2025-12-19 |
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