Identity
- Trade Name
- UNITY FDA UDI
- Generic Name
- Phacoemulsification/vitrectomy system FDA UDI
- Device Name
- LASER KIT FDA UDI
- Model / Reference
- 00380650002433 FDA UDI
- Description
- LASER KIT FDA UDI
Identifiers
- Catalog Number
- 8065000243 FDA UDI
- Primary DI / UDI-DI
- 00380650002433 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Phacoemulsification/vitrectomy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Phacoemulsification/vitrectomy system
Unity by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Phacoemulsification/vitrectomy system.
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- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- EVA, combined machine including Laser (DORC connector) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- EVA NEXUS™, Phaco emulsification system — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI 8efeb498-9e42-4303-a388-785857b094fb 34 fields · synced Jun 1, 2026