Identity
- Trade Name
- Eyelite, PurePoint, Alcon FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- Eyelite/PurePoint Eye Safety Filter FDA UDI
- Model / Reference
- 8065-5002-01 FDA UDI
- Description
- Eyelite/PurePoint Eye Safety Filter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380655002018 FDA UDI
- FDA Product Code
- HQF FDA UDIGEX FDA UDI
- GMDN Term
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 FDA UDI878.4810 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: General/multiple surgical frequency-doubled solid-state laser system
Eyelite, PurePoint, Alcon by Alcon Laboratories, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical frequency-doubled solid-state laser system.
- GREEN LASER PHOTOCOAGULATOR SYSTEM — Nidek, Inc. · Class II
- GreenLight HPS — AMERICAN MEDICAL SYSTEMS, INC. · Class II
- SPECTRA — Lutronic Corporation · Class II
- Scan attachable delivery unit (30SL/M) — Nidek, Inc. · Class II
- Powered Laser Surgical Instrument－Nice Station Light Based Platform — Beijing Syntech Laser Co., Ltd. · Class II
- Scan attachable delivery unit (SL130) — Nidek, Inc. · Class II
- GreenLight™ Laser System Footswitch — Boston Scientific · Class II
- BIO delivery unit (Keeler) — Nidek, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (2)
- FDA UDI 40cf2efc-4774-4001-99a6-22072b701bd6 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026