# Rolence Enterprise Co., Ltd.

- Location (FDA's records): Chungli, Taiwan, TW
- FDA decisions: 14 (1993–2021): 14 510(k) clearances
- Names in FDA's records: Rolence Enterprise Co. , Ltd. (12); Rolence Enterprise, Inc. (2)
- Product codes: EBZ (8), EBF (3), MUH (1), EHK (1), EHD (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 5 (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
- Masterlink, LLC: 1 (https://510kreport.com/company/masterlink)
- Aribex, Inc.: 1 (https://510kreport.com/company/aribex)

## Firms that cite its devices most
- Ics of North America, Inc.: 2 (https://510kreport.com/company/ics-of-north-america)
- Mediphotonix, LC: 2 (https://510kreport.com/company/mediphotonix-lc)
- Eele Laboratories, LLC: 1 (https://510kreport.com/company/eele-laboratories)

## Its most-cited devices
- K980793: Q-Luxpro V/Q-Luxpro II Light Cure Unit (1998), cited by 2
- K980792: CU-100A Light Cure Unit (1998), cited by 2
- K001719: Q-Lux Plasma 100 Light Cure Unit (2000), cited by 1

## Recent decisions
- K202369: RXS 1000 (Sep 15, 2021)
- K172928: Portable X-ray System (Mar 16, 2018)
- K001719: Q-Lux Plasma 100 Light Cure Unit (Oct 10, 2000)
- K991865: Q-Lite 75 Light Cure Unit (Jul 20, 1999)
- K991863: Cute-Lite I Light Cure Unit (Jul 19, 1999)
- K980793: Q-Luxpro V/Q-Luxpro II Light Cure Unit (May 15, 1998)
- K980792: CU-100A Light Cure Unit (May 15, 1998)
- K960364: CU-200 Light Cure Unit (Apr 15, 1996)

Source page: https://510kreport.com/company/rolence-enterprise