# K230293: TheraFace Mask

- Pathway: 510(k) (Traditional)
- Applicant: Therabody, Inc.
- Decided: Jun 9, 2023 after 127 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 166 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213184: MZ Skin LightMAX Supercharged LED Mask 2.0, Mz Skin (2021) Summary page 4.
- K192295: PDT-Face, Beijing Adss Development Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own
- K242796: CryoGlow (FW3XXXX) (2024), 4 descendants of its own
- K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (2025), 2 descendants of its own
- K240360: Wrinkle Treatment Device (JM2) (2024), 2 descendants of its own
- K250761: KALA Therapy Wand (Model: KALA-03) (2025), 1 descendant of its own

## Indications for use
Red Light is intended to treat full face wrinkles Blue Light is intended to treat mild to moderate inflammatory acne Red + Infrared Light is intended to treat full face wrinkles

Source page: https://510kreport.com/device/K230293
Methodology: https://510kreport.com/methodology