Identity
- Trade Name
- 25GA Straight Laser Probe, SMA905 FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- 25GA Straight Laser Probe, SMA905 FDA UDI
- Model / Reference
- GA-0042250 FDA UDI
- Description
- 25GA Straight Laser Probe, SMA905 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00632307002106 FDA UDI
- 510(k) Number
- K024061 FDA UDI
- FDA Product Code
- HQF FDA UDIGEX FDA UDI
- GMDN Term
- Ophthalmic laser system beam guide 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDI
Category: Ophthalmic laser system beam guide
25GA Straight Laser Probe, SMA905 by Peregrine 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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- Synergetics — SYNERGETICS USA, INC. · Class II
- 23-27G BriteLight™ Angled 45° EndoProbe® Box of 6 — Iridex Corporation · Class II
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- OtoProbe™ Short Angled Box of 6 — Iridex Corporation · Class II
Cleared under the same submission
K024061 also covers:
- 20GA Curved Laser Probe with Alcon adaptor — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 20GA Straight Laser Probe with Alcon adaptor — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 23GA Straight Laser Probe with Alcon adaptor — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 25GA Straight Laser Probe with Alcon adaptor — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Laser Probe, straight, with DORC connector 20 gauge / 0.9mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Laser Probe, straight, with DORC connector 23 gauge / 0.6mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Laser Probe, straight, with DORC connector 25 gauge / 0.5mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Laser probe, curved, with DORC connector 20 gauge / 0.9mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Stepped Laser probe, 25 gauge / 0, 5mm with Alcon® connector — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Stepped Laser probe, 25 gauge / 0, 5mm with DORC® connector — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Stepped Laserprobe, with Alcon connector. (23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Stepped Laserprobe, with DORC connector. (23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
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
- Peregrine Surgical, LLC.
Sources (1)
- FDA UDI a1c366b7-7c42-4722-b955-8512757491dc 36 fields · synced Jun 1, 2026