Medical Device Manufacturer · TW , Chungli, Taiwan

Rolence Enterprise Co. , Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1993

Recent clearances: Q-LITE 75 LIGHT CURE UNIT, CUTE-LITE I LIGHT CURE UNIT, CU-100A LIGHT CURE UNIT

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rolence Enterprise Co. , Ltd. Dental ✕

12 devices

1-12 of 12

Cleared Oct 10, 2000

Q-LUX PLASMA 100 LIGHT CURE UNIT

Cleared Jul 20, 1999

Q-LITE 75 LIGHT CURE UNIT

Cleared Jul 19, 1999

CUTE-LITE I LIGHT CURE UNIT

Cleared May 15, 1998

CU-100A LIGHT CURE UNIT

Cleared May 15, 1998

Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT

Cleared Apr 15, 1996

Q-LUX LIGHT CURE UNIT

Cleared Apr 15, 1996

CU-200 LIGHT CURE UNIT

Cleared Sep 29, 1995

Cleared Jun 22, 1995

CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676

Cleared Jun 02, 1994

CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676

Cleared May 27, 1994

CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676

Cleared Jun 17, 1993

100 LIGHT CURE UNIT