510(k) K253683
- Device
- FAQ™ (LED Panel); FAQ™ (Dual LED Panel)
- Applicant
- Foreo, Inc.
- 510(k) number
- K253683
- Product code
- OHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-20
- Date received
- 2025-11-21
- 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
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Feldstein Evan
- Address
- 1525 E Pama Ln. Las Vegas NV US 89119 89119
FDA Registration Numbers#
- 3013423303
- 3033793026
- 3015415349
- 3012327767
- 3017422691
- 3027645761
- 1318319
- 3016496662
- 3017618922
- 3008592814
- 3016879560
- 3030541658
- 3023339103
- 3010677917
- 3014467408
- 3007238544
- 3023339107
- 3017953405
- 3009765778
- 3020659203
- 3029972385
- 3019577501
- 3016171836
- 3012512142
- 3012113199
- 3017619615
- 3039304811
- 3043749884
- 3013995763
- 3015313684
- 3022327202
- 3030194742
- 3009102830
- 3022426824
- 3015619973
- 3010402752
- 3010360273
- 3042970900
- 3017103444
- 3021282471
- 3037341611
- 3008929787
- 3007689716
- 3016750352
- 3018994966
- 3038373471
- 3011564440
- 3013397886
- 3031595583
- 3038319732
- 3019015047
- 3013738756
- 3037031835
- 3030234086
- 3016055197
- 3017649333
- 3015924074
- 9617486
- 3008345424
- 3014737458
- 3017382141
- 3014545271
- 3006546131
- 3004126239
- 3015974280
- 3011644607
- 3006182559
- 3007744197
- 3010027944
- 3016071154
- 3018188770
- 3039443706
- 3012470925
- 3013481783
- 3017140525
- 3006459199
- 3015287734
- 3024892917
- 3013178978
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OHS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026-03-23 |