The following data is part of a premarket notification filed by Clearlab Sg Pte, Ltd with the FDA for Clearcolor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens.
| Device ID | K192129 |
| 510k Number | K192129 |
| Device Name: | ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Clearlab SG Pte, Ltd 139 Joo Seng Road #01-01 Singapore, SG 368362 |
| Contact | John Christopher Phelan |
| Correspondent | John Christopher Phelan Clearlab US, Inc. 4200 Jenkins Ct Suwanee, GA 30024 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-07 |
| Decision Date | 2019-09-27 |
| Summary: | summary |