Identity
- Trade Name
- 20GA Hard Tip Aspirating Laser Probe - Alcon FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- 20GA Hard Tip Aspirating Laser Probe - Alcon FDA UDI
- Model / Reference
- PD720.60HT FDA UDI
- Description
- 20GA Hard Tip Aspirating Laser Probe - Alcon FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00632307000287 FDA UDI
- 510(k) Number
- K061024 FDA UDI
- FDA Product Code
- HQE FDA UDIHQF FDA UDI
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4150 FDA UDI886.4390 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 — 20 Gauge FDA UDI
Category: Ophthalmic laser system beam guide
20GA Hard Tip Aspirating Laser Probe - Alcon by Peregrine Surgical, LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic laser system beam guide.
- CURVED LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4 — FCI S A S FCI 20 22 · Class II
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- 23-27G BriteLight™ Angled 45° EndoProbe® Box of 6 — Iridex Corporation · Class II
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- Synergetics — SYNERGETICS USA, INC. · Class II
- OtoProbe™ Short Angled Box of 6 — Iridex Corporation · Class II
Cleared under the same submission
K061024 also covers:
- Bausch + Lomb — Bausch & Lomb Incorporated
- Bausch + Lomb — Bausch & Lomb Incorporated
- Bausch + Lomb — Bausch & Lomb Incorporated
- Bausch + Lomb — Bausch & Lomb Incorporated
- 20GA Aspirating Laser Probe, SMA905 — Peregrine Surgical, LLC.
- 20GA Aspirating Laser Probe, SMA906 — Peregrine Surgical, LLC.
- 20GA Hard Tip Aspirating Laser Probe - Iridex — Peregrine Surgical, LLC.
- 20GA Soft Tip Aspirating Laser Probe - Alcon — Peregrine Surgical, LLC.
- 20GA Soft Tip Aspirating Laser Probe - Iridex — Peregrine Surgical, LLC.
- 23GA Hard Tip Aspirating Laser Probe - Alcon — Peregrine Surgical, LLC.
- 23GA Hard Tip Aspirating Laser Probe - Iridex — Peregrine Surgical, LLC.
- 23GA Soft Tip Aspirating Laser Probe - Alcon — Peregrine 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
- Peregrine Surgical, LLC.
Sources (1)
- FDA UDI 1823e5e3-0920-45ca-8fd0-5076e0ce7ed6 36 fields · synced Jun 8, 2026