510(k) K212275
- Device
- Dermalux Flex MD
- Applicant
- Aesthetic Technology Ltd.
- 510(k) number
- K212275
- Product code
- OHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-18
- Date received
- 2021-07-20
- 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
- Dale Needham
- Address
- Unit 211 Europa Blvd. Warrington GB WA5 7TN WA5 7TN
FDA Registration Numbers#
- 1318319
- 3019577501
- 3016076077
- 3014545271
- 3038373471
- 3026890286
- 3010724743
- 3004450661
- 3017382141
- 3027651556
- 3037031835
- 1832894
- 3011644607
- 3010360273
- 3015289316
- 3016071154
- 3019015047
- 3038319732
- 3043165181
- 3015603281
- 3007554929
- 3014386328
- 3044622318
- 3017619615
- 3023339107
- 3018188770
- 3015619973
- 3011564440
- 3016879560
- 3012470925
- 3007689716
- 3016055197
- 3013689783
- 3015974280
- 3015313684
- 3031595583
- 3004167969
- 3008929787
- 3007744197
- 3044572954
- 3006459199
- 3012512142
- 3030541658
- 3022327202
- 3017555752
- 3027645761
- 3022426824
- 3015646995
- 3015287734
- 3035785623
- 3042970900
- 3008592814
- 3017618922
- 3038214786
- 3015924074
- 3030194742
- 3037341611
- 3019864920
- 3033793026
- 3021282523
- 3014737458
- 3013481783
- 3008345424
- 3010027944
- 3033847811
- 3016171836
- 3013178978
- 3029972385
- 3010677917
- 3013397886
- 3036720861
- 3017103444
- 3023339103
- 3030234143
- 3020900954
- 3021599225
- 3017953405
- 3009765778
- 3012294783
- 3016496662
Source Documents#
Other 510(k) Records For Product Code OHS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
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