2 Face / Face Evolution
510(k) K171821
2 Face / Face Evolution is a medical device (FDA Class II; FDA product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes) made by Heat IN A Click, cleared under FDA 510(k) K171821 on 26 Apr 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171821 | Date26 Apr 2018 | StatusActive |
Official records
- FDA 510(k) database K171821
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NFO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K171821
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Lumina NRG 6626 | 6626 | 00850018806626 | — | On the market |
| Numiere 6602 | 6602 | 00850018806602 | — | On the market |
| Numiere SM9916 | SM9916 | 06971712722976 | — | On the market |
Similar devices
Other devices filed under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).
- Rejuvenique Model #RJV10 by Salton, Inc.
- MF SC Facial Toning System by Micro Current Technology, Inc.
- Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) by Shenzhen Jianchao Intelligent Technology Co., Ltd.
- Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) by Shenzhen Nuon Medical Equipment Co., Ltd.
- SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 by Geske Beauty Tech GmbH
- Myolift QT by Johari Digital Healthcare, Ltd.
- NUFACE, MODEL NU-4003 by Carol Cole Company
- FACEMASTER FACIAL TONING SYSTEM by Facemaster of Beverly Hills, Inc.
- AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM by Leto Enterprise, Ltd.
- LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) by Guangdong Newdermo Biotech Co., Ltd.