← Back to catalogue
ACUVUE Abiliti Overnight Therapeutic lenses for myopia management
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- ACUVUE Abiliti Overnight Therapeutic lenses for myopia management FDA UDI
- Generic Name
- Orthokeratology contact lens FDA UDI
- Model / Reference
- ACUVUE Abiliti FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192538951357 FDA UDI
- FDA Product Code
- NUU FDA UDI
- GMDN Term
- Orthokeratology contact lens FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.5916 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthokeratology contact lens
ACUVUE Abiliti Overnight Therapeutic lenses for myopia management by Menicon Co., Ltd. — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthokeratology contact lens.
- Paragon RG-4 — Paragon Vision Sciences · Class III
- Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Paragon HDS100 — Paragon Vision Sciences · Class II
- Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Menicon Co., Ltd.
Sources (1)
- FDA UDI d012ac93-88eb-41f5-8a5e-9f5cced96ccb 32 fields · synced May 30, 2026