Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180985 FDA 510(k)
- FDA Product Code
- LPL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5925 FDA 510(k)
- Regulation Number
- 886.5925 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses are soft contact lenses made of hydrophilic material intended for vision correction. They are classified as Lenses, Soft Contact, Daily Wear under product code LPL and are designed for daily wear use.
These lenses are supplied as disposable wear and are to be discarded after each removal when prescribed for daily disposable wear. They may be disinfected using a chemical disinfection system. The device is a Class II medical device cleared via the FDA 510(k) pathway under K180985 and is manufactured by Supervision Optimax Sdn Bhd.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses (K180985) — FDA ..., aveo omafilcon a Soft Hydrophilic Contact Lenses - Supervision Optimax ..., K180985 FDA 510(k) - Aveo (omafilcon A) Soft (Hydrophilic) C...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180985 | Class II | Active |
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Manufacturer
- Manufacturer
- Supervision Optimax Sdn. Bhd.
- FDA Applicant
- Supervision Optimax Sdn Bhd
Sources (1)
- FDA 510(k) K180985 24 fields · synced Sep 24, 2026