Rolence Enterprise Co. , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT | October 10, 2000 |
| K991865 | Q-LITE 75 LIGHT CURE UNIT | July 20, 1999 |
| K991863 | CUTE-LITE I LIGHT CURE UNIT | July 19, 1999 |
| K980792 | CU-100A LIGHT CURE UNIT | May 15, 1998 |
| K980793 | Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT | May 15, 1998 |
| K960351 | Q-LUX LIGHT CURE UNIT | April 15, 1996 |
| K960364 | CU-200 LIGHT CURE UNIT | April 15, 1996 |
| K953628 | PROPHY ANGLE | September 29, 1995 |
| K952423 | CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 | June 22, 1995 |
| K942199 | CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 | June 2, 1994 |
| K942198 | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 | May 27, 1994 |
| K924727 | 100 LIGHT CURE UNIT | June 17, 1993 |