The following data is part of a premarket notification filed by Apoza Enterprise Co. Ltd. with the FDA for La500 Blue Light.
| Device ID | K033201 |
| 510k Number | K033201 |
| Device Name: | LA500 BLUE LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | APOZA ENTERPRISE CO. LTD. 6 F,NO.657, CHUANG CHENG ROAD HSIN-CHUANG CITY Taipei Hsien, TW 242 |
| Contact | Shih Min-teh |
| Correspondent | Shih Min-teh APOZA ENTERPRISE CO. LTD. 6 F,NO.657, CHUANG CHENG ROAD HSIN-CHUANG CITY Taipei Hsien, TW 242 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-02 |
| Decision Date | 2003-12-02 |
| Summary: | summary |