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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Rolence Enterprise Co. , Ltd. · Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

74 daysmedian FDA review time
127 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K001719Q-LUX PLASMA 100 LIGHT CURE UNITRolence Enterprise Co. , Ltd.2000-10-101270
K991865Q-LITE 75 LIGHT CURE UNITRolence Enterprise Co. , Ltd.1999-07-20490
K991863CUTE-LITE I LIGHT CURE UNITRolence Enterprise Co. , Ltd.1999-07-19480
K980793Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNITRolence Enterprise Co. , Ltd.1998-05-15740
K980792CU-100A LIGHT CURE UNITRolence Enterprise Co. , Ltd.1998-05-15740
K960364CU-200 LIGHT CURE UNITRolence Enterprise Co. , Ltd.1996-04-15810
K960351Q-LUX LIGHT CURE UNITRolence Enterprise Co. , Ltd.1996-04-15810
K953628PROPHY ANGLERolence Enterprise Co. , Ltd.1995-09-29600
K952423CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676Rolence Enterprise Co. , Ltd.1995-06-22300
K942199CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676Rolence Enterprise Co. , Ltd.1994-06-02280
K942198CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676Rolence Enterprise Co. , Ltd.1994-05-27220
K924727100 LIGHT CURE UNITRolence Enterprise Co. , Ltd.1993-06-172690

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda