510(k) K191121
K191121 is an FDA 510(k) premarket notification submitted by Lentechs, LLC for the device "Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens". The FDA issued a decision of Substantially Equivalent on Sep 6, 2019. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 6, 2019
- Date Received
- Apr 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lenses, Soft Contact, Daily Wear
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type
- 510(k)