The following data is part of a premarket notification filed by X6d, Ltd. with the FDA for Amb101 System, Amblyz, Lcg System, Xpand.
| Device ID | K132042 |
| 510k Number | K132042 |
| Device Name: | AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | X6D, LTD. 21 HANAFA STREET Zur- Moshe, IL 42810 |
| Contact | Karel Van Gorp |
| Correspondent | Karel Van Gorp X6D, LTD. 21 HANAFA STREET Zur- Moshe, IL 42810 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-02 |
| Decision Date | 2014-04-28 |
| Summary: | summary |