The following data is part of a premarket notification filed by Menicon Co., Ltd. with the FDA for Menicon Asrb (asmofilcon A) Silicone Hydrogel Soft Contact Lens.
| Device ID | K180004 |
| 510k Number | K180004 |
| Device Name: | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku Nagoya, JP 460-0006 |
| Contact | Kenichi Tanaka |
| Correspondent | Ellen M. Beucler Foresight Regulatory Stategies, Inc. 187 Ballardvale Street, Suite A250 Wilmington, MA 01887 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-02 |
| Decision Date | 2018-02-22 |
| Summary: | summary |