The following data is part of a premarket notification filed by Rolence Enterprise Co. Ltd. with the FDA for Q-lux Plasma 100 Light Cure Unit.
| Device ID | K001719 |
| 510k Number | K001719 |
| Device Name: | Q-LUX PLASMA 100 LIGHT CURE UNIT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | ROLENCE ENTERPRISE CO. LTD. 18-3 LANE 231 PU CHUNG RD. Chungli 320, TW |
| Contact | Sterling Cheng |
| Correspondent | Sterling Cheng ROLENCE ENTERPRISE CO. LTD. 18-3 LANE 231 PU CHUNG RD. Chungli 320, TW |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-05 |
| Decision Date | 2000-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817169021414 | K001719 | 000 |
| 04713909450406 | K001719 | 000 |
| 04713909450390 | K001719 | 000 |
| D861LED39N0 | K001719 | 000 |
| D861ALED70N0 | K001719 | 000 |
| D861ALED60N0 | K001719 | 000 |
| D861ALED55N0 | K001719 | 000 |
| D861ALED55BN0 | K001719 | 000 |
| D861ALED500 | K001719 | 000 |
| 04713909450413 | K001719 | 000 |
| 04713909450420 | K001719 | 000 |
| 00817169021391 | K001719 | 000 |
| 04713909450505 | K001719 | 000 |
| 04713909450482 | K001719 | 000 |
| 04713909450475 | K001719 | 000 |
| 04713909450468 | K001719 | 000 |
| 04713909450451 | K001719 | 000 |
| 04713909450444 | K001719 | 000 |
| 04713909450437 | K001719 | 000 |
| D861ALED25000 | K001719 | 000 |