Identity
- Trade Name
- Bausch + Lomb FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- 20G HT ASP L PROBE 5/BOX FDA UDI
- Model / Reference
- BL5290ASPH FDA UDI
- Description
- 20G HT ASP L PROBE 5/BOX FDA UDI
Identifiers
- Catalog Number
- BL5290ASPH FDA UDI
- Primary DI / UDI-DI
- 10757770507624 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
No
FDA UDI
Category: Ophthalmic laser system beam guide
Bausch + Lomb by Bausch & Lomb Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K061024 also covers:
- 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 - Alcon — 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
- Bausch & Lomb Incorporated
Sources (1)
- FDA UDI 55793eb7-e9ac-4b50-9237-38a47634cf61 35 fields · synced Jun 8, 2026