# OHS: Light Based Over The Counter Wrinkle Reduction

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 165
- 510(k) review time 2021–2025: median 90 days (middle half 85–134)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 8
- 2018: 7
- 2019: 4
- 2020: 2
- 2021: 7
- 2022: 16
- 2023: 12
- 2024: 16
- 2025: 42
- 2026: 26

## Most-cited predicates
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), cited by 13
- K120775: Light for Wrinkles (2012), cited by 11
- K230351: LED Facial Mask (2023), cited by 9
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), cited by 9
- K191629: faceLITE (2019), cited by 7
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023) (2023), cited by 7
- K241718: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (2024), cited by 7
- K171323: Biophotas CELLUMA3 (2017), cited by 7
- K240089: Face Patches (MT-12MA, MT-12MC) (2024), cited by 6
- K171390: dpl II Panel (2017), cited by 6

Source page: https://510kreport.com/product-code/OHS
Data by year (CSV): https://510kreport.com/product-code/OHS.csv