# iSMART Developments, Ltd.

- Location (FDA's records): Birmingham, GB
- FDA decisions: 4 (2023–2026): 4 510(k) clearances
- Product codes: OHS (3), ONE (1)
- 510(k) review time since 2016: median 88 days, against 88 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ismart Marketing Svcs, Ltd.: 2 (https://510kreport.com/company/ismart-marketing-svcs)
- Mz Skin: 1 (https://510kreport.com/company/mz-skin)
- Ambicare Health, Ltd.: 1 (https://510kreport.com/company/ambicare-health)
- Philips Electronics Nederland B.V.: 1 (https://510kreport.com/company/philips-electronics-nederland)
- Silver Bay, LLC: 1 (https://510kreport.com/company/silver-bay)

## Firms that cite its devices most
- Shenzhen Kaiyan Medical Equipment Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-kaiyan-medical-equipment)
- Guangdong Ace-Tec Co., Ltd.: 1 (https://510kreport.com/company/guangdong-ace-tec)
- Merchsource, LLC: 1 (https://510kreport.com/company/merchsource)
- Sunglor Technology Co., Ltd.: 1 (https://510kreport.com/company/sunglor-technology)
- Heat IN A Click, LLC: 1 (https://510kreport.com/company/heat-in-a-click)

## Its most-cited devices
- K242382: décoLITE LED Device (2024), cited by 5
- K231555: LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) (2023), cited by 1

## Recent decisions
- K260598: 5 Wavelength LED Facemask (TN2508) (Jul 24, 2026)
- K250224: handLITE (TN19S) (Apr 18, 2025)
- K242382: décoLITE LED Device (Nov 8, 2024)
- K231555: LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) (Jul 27, 2023)

Source page: https://510kreport.com/company/ismart-developments