The following data is part of a premarket notification filed by The Lagado Corp. with the FDA for Lsh (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens, Lsh (mangofilcon A) Multifocal Soft (hydrophilic) Contact Le.
| Device ID | K120756 |
| 510k Number | K120756 |
| Device Name: | LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | THE LAGADO CORP. 218 E. COMMERCIAL BLVD STE # 201-Q Lauderdale By The Sea, FL 33308 |
| Contact | Ellen Beucler |
| Correspondent | Ellen Beucler THE LAGADO CORP. 218 E. COMMERCIAL BLVD STE # 201-Q Lauderdale By The Sea, FL 33308 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-13 |
| Decision Date | 2013-05-13 |
| Summary: | summary |