Identity
- Trade Name
- 25ga Revolver Straight Illuminated FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- Box of 10, 25ga Revolver Straight Illuminated FDA UDI
- Model / Reference
- V6630-25 FDA UDI
- Description
- Box of 10, 25ga Revolver Straight Illuminated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817489024652 FDA UDI
- 510(k) Number
- K121187 FDA UDI
- FDA Product Code
- HQB FDA UDI
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4690 FDA UDI
- Commercial Distribution
- 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
Category: Ophthalmic laser system beam guide
25ga Revolver Straight Illuminated by Katalyst Surgical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic laser system beam guide.
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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 9024ad21-49ef-4490-a208-8014f9f6f7c8 34 fields · synced Jun 1, 2026