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Scan Attachable delivery unit (SL130)
FDA UDIClass II (US FDA UDI)
by Nidek, Inc.
Identity
- Trade Name
- Scan Attachable delivery unit (SL130) FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- The delivery unit is connected to the YELLOW LASER PHOTOCOAGULATOR YLC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a yellow laser beam (577 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system (SOLIC *1) that ensures low laser power density on the anterior segment is incorporated. The ZEISS SL130 type is available. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). The ZEISS SL130 type is available: *1 Safety Optics with Low Impact on Cornea FDA UDI
- Model / Reference
- GEA01 FDA UDI
- Description
- The delivery unit is connected to the YELLOW LASER PHOTOCOAGULATOR YLC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a yellow laser beam (577 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system (SOLIC *1) that ensures low laser power density on the anterior segment is incorporated. The ZEISS SL130 type is available. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). The ZEISS SL130 type is available: *1 Safety Optics with Low Impact on Cornea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101179 FDA UDI
- FDA Product Code
- HQF 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 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
No
FDA UDI
Category: General/multiple surgical frequency-doubled solid-state laser system
Scan Attachable delivery unit (SL130) by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Nidek, Inc.
Sources (1)
- FDA UDI c1bccbad-b50b-4689-880b-d78dcab92ff5 34 fields · synced May 30, 2026