Rolence Enterprise Co. , Ltd.
Rolence Enterprise Co. , Ltd. has 0 FDA recalls, 0 inspections, 14 510(k) clearances and 0 compliance actions on record.
- Latest 510(k)
- Sep 15, 2021
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 14 | Oct 4, 2026 | Not stated | Current |
| Inspections | 0 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| 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 |
| K960351 | Q-LUX LIGHT CURE UNIT | Apr 15, 1996 |
| K953628 | PROPHY ANGLE | Sep 29, 1995 |
| K952423 | CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 | Jun 22, 1995 |
| K942199 | CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 | Jun 2, 1994 |
| K942198 | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 | May 27, 1994 |
| K924727 | 100 LIGHT CURE UNIT | Jun 17, 1993 |