# K242796: CryoGlow (FW3XXXX)

- Pathway: 510(k) (Traditional)
- Applicant: Sharkninja Operating, LLC
- Decided: Nov 27, 2024 after 72 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: 17 generations back to K943450 (1995). 167 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230293: TheraFace Mask, Therabody, Inc. (2023) Summary page 5.

## Most influential descendants
- K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (2025), 2 descendants of its own
- K260715: CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (2026), 0 descendants of its own
- K253054: LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (2025), 0 descendants of its own
- K252994: LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) (2025), 0 descendants of its own

## Indications for use
The CryoGlow LED mask emits energy in the red and infrared light spectrum for the treatment of fine lines and wrinkles and in the red, blue, and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne.

Source page: https://510kreport.com/device/K242796
Methodology: https://510kreport.com/methodology