Identity
- Trade Name
- 25ga Skinny Steerable Laser Probe, Nidek Thread FDA UDI
- Generic Name
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
- Device Name
- Box of 10, 25ga Skinny Steerable Laser Probe, Nidek Thread FDA UDI
- Model / Reference
- V6530-25E FDA UDI
- Description
- Box of 10, 25ga Skinny Steerable Laser Probe, Nidek Thread FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817489020838 FDA UDI
- 510(k) Number
- K121187 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
25ga Skinny Steerable Laser Probe, Nidek Thread by Katalyst Surgical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K121187 also covers:
- 20ga Curved Laser Probe, Quantel — KATALYST SURGICAL, LLC
- 20ga Endo-Ocular Probe-Straight, Alcon Compatible — KATALYST SURGICAL, LLC
- 20ga Straight Laser Probe, DORC — KATALYST SURGICAL, LLC
- 23ga Endo-Ocular Probe- Flexible Curved, Quantel Compatible — KATALYST SURGICAL, LLC
- 23ga Endo-Ocular Probe-Straight — KATALYST SURGICAL, LLC
- 23ga Endo-Ocular Probe-Straight, Iridex Compatible — KATALYST SURGICAL, LLC
- 23ga Endo-Ocular Probes Steerable — KATALYST SURGICAL, LLC
- 23ga Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector — KATALYST SURGICAL, LLC
- 23ga Straight Laser Probe, DORC — KATALYST SURGICAL, LLC
- 23ga Straight Laser Probe, Quantel — KATALYST SURGICAL, LLC
- 23ga Tapered Flexible Curved Laser Probe, Nidek Thread — KATALYST SURGICAL, LLC
- 23ga MultiFlex™ Inverted Laser Probe, Iridex Connector — KATALYST SURGICAL, LLC
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
- Katalyst Surgical, Llc
Sources (1)
- FDA UDI f5c6bd07-a95e-4ada-93f2-9d0a95ce2aab 35 fields · synced Jun 1, 2026