Company ยท TW
Rolence Enterprise Co. , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2021. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2021 | K202369 | RXS 1000 Rolence Enterprise, Inc., TW | MUH |
| Mar 16, 2018 | K172928 | Portable X-ray System Rolence Enterprise, Inc., TW | EHD |
| Oct 10, 2000 | K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| Jul 20, 1999 | K991865 | Q-LITE 75 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| Jul 19, 1999 | K991863 | CUTE-LITE I LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| May 15, 1998 | K980793 | Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBF |
| May 15, 1998 | K980792 | CU-100A LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBF |
| Apr 15, 1996 | K960364 | CU-200 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| Apr 15, 1996 | K960351 | Q-LUX LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| Sep 29, 1995 | K953628 | PROPHY ANGLE Rolence Enterprise Co. , Ltd., TW | EHK |
| Jun 22, 1995 | K952423 | CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 Rolence Enterprise Co. , Ltd., TW | EBZ |
| Jun 2, 1994 | K942199 | CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 Rolence Enterprise Co. , Ltd., TW | EBZ |
| May 27, 1994 | K942198 | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 Rolence Enterprise Co. , Ltd., TW | EBZ |
| Jun 17, 1993 | K924727 | 100 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||