Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
FDA 510(k) clearance K201268 · decided 2020-10-21
Clearance details
- K-number
- K201268
- Device name
- Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
- Applicant
- Plexus Optix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-12
- Decision date
- 2020-10-21
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rancho Cordova, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.