The following data is part of a premarket notification filed by Monitex Industrial Co., Ltd. with the FDA for Led Curing Light Gt-2000.
| Device ID | K153078 |
| 510k Number | K153078 |
| Device Name: | LED Curing Light GT-2000 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | MONITEX INDUSTRIAL CO., LTD. 6F, 70 SEC. 1 GUANG-FU ROAD SAN-CHONG DIST. New Taipei City, TW 241-58 |
| Contact | Shu-lung Wang |
| Correspondent | Shu-lung Wang MONITEX INDUSTRIAL CO., LTD. 6F, 70 SEC. 1 GUANG-FU ROAD SAN-CHONG DIST. New Taipei City, TW 241-58 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-23 |
| Decision Date | 2016-06-28 |