Rolence Enterprise Co., Ltd.
Chungli 320, TW
Rolence Enterprise Co. , Ltd. appears in FDA device records in Chungli 320, TW. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Rolence Enterprise Co., Ltd. between 1993 and 2021. The busiest year on record is 1994, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 2 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202369 | RXS 1000 | MUH | Substantially Equivalent | |
| K172928 | Portable X-ray System | EHD | Substantially Equivalent | |
| K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT | EBZ | Substantially Equivalent | |
| K991865 | Q-LITE 75 LIGHT CURE UNIT | EBZ | Substantially Equivalent | |
| K991863 | CUTE-LITE I LIGHT CURE UNIT | EBZ | Substantially Equivalent | |
| K980793 | Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT | EBF | Substantially Equivalent | |
| K980792 | CU-100A LIGHT CURE UNIT | EBF | Substantially Equivalent | |
| K960364 | CU-200 LIGHT CURE UNIT | EBZ | Substantially Equivalent | |
| K960351 | Q-LUX LIGHT CURE UNIT | EBZ | Substantially Equivalent | |
| K953628 | PROPHY ANGLE | EHK | Substantially Equivalent | |
| K952423 | CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 | EBZ | Substantially Equivalent | |
| K942199 | CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 | EBZ | Substantially Equivalent | |
| K942198 | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 | EBZ | Substantially Equivalent | |
| K924727 | 100 LIGHT CURE UNIT | EBF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain