AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
FDA 510(k) clearance K140025 · decided 2014-10-15
Clearance details
- K-number
- K140025
- Device name
- AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
- Applicant
- Pegavision Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-01-06
- Decision date
- 2014-10-15
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Taoyuan, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.