Identity
- Trade Name
- 25ga Skinny Steerable Laser Probe, Iridex FDA UDI
- Generic Name
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
- Device Name
- Box of 10, 25ga Skinny Steerable Laser Probe, Iridex FDA UDI
- Model / Reference
- V6530-25A FDA UDI
- Description
- Box of 10, 25ga Skinny Steerable Laser Probe, Iridex FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817489020807 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, Iridex 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 26985c7b-4ffb-4f3e-9db7-962b7ed7a927 35 fields · synced May 31, 2026