The following data is part of a premarket notification filed by The Lagado Corp. with the FDA for Progent Large Diameter Contact Lens Case For Rigid Gas Permeable Lens.
| Device ID | K130285 |
| 510k Number | K130285 |
| Device Name: | PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS |
| Classification | Case, Contact Lens |
| Applicant | THE LAGADO CORP. 187 BALLARDVALE STREET SUITE 180 Wilmington, MA 01887 |
| Contact | Ellen M Beucler |
| Correspondent | Ellen M Beucler THE LAGADO CORP. 187 BALLARDVALE STREET SUITE 180 Wilmington, MA 01887 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-05 |
| Decision Date | 2013-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192538901079 | K130285 | 000 |