The following data is part of a premarket notification filed by Abb Optical Group, Llc with the FDA for Biolens Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens For Daily Wear, Biolens Toric (mangofilcon A) Soft (hydrophilie) Contact Lens For Daily Wear, Biolens Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens For Daily Wear, Biolens To.
| Device ID | K142820 |
| 510k Number | K142820 |
| Device Name: | BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens For Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens For Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens For Daily Wear, BIOLENS To |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ABB Optical Group, LLC 1750 N. Loop Road, Ste. 150 Alameda, CA 94502 |
| Contact | John Kenyon |
| Correspondent | Kevin Randall Compliance Acuity, Inc. P.O. Box 1490 Golden, CO 80402 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-04-30 |
| Summary: | summary |