Identity
- Trade Name
- ScopeSafe™Laser Fiber FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- 1000 micrometer ScopeSafe laser fiber, Convergent compatible, reusable FDA UDI
- Model / Reference
- 10850 FDA UDI
- Description
- 1000 micrometer ScopeSafe laser fiber, Convergent compatible, reusable FDA UDI
Identifiers
- Primary DI / UDI-DI
- B145108500 FDA UDI
- 510(k) Number
- K022338 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
- Outer Diameter — 1000 Micrometer FDA UDI
Category: General/multiple surgical laser system beam guide, reusable
ScopeSafe™Laser Fiber by Optical Integrity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical laser system beam guide, reusable.
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Cleared under the same submission
K022338 also covers:
- InnoVoyce LLC — InnoVoyce LLC
- InnoVoyce LLC — InnoVoyce LLC
- Calculase Laser Fiber — OPTICAL INTEGRITY, INC.
- Calculase Laser Fiber — OPTICAL INTEGRITY, INC.
- Calculase Laser Fiber — OPTICAL INTEGRITY, INC.
- Optical Integrity Laser Fiber — OPTICAL INTEGRITY, INC.
- Optical Integrity Laser Fiber — OPTICAL INTEGRITY, INC.
- Optical Integrity Laser Fiber — OPTICAL INTEGRITY, INC.
- Optical Integrity Laser Fiber — OPTICAL INTEGRITY, INC.
- Optical Integrity Laser Fiber — OPTICAL INTEGRITY, INC.
- Optical Integrity Laser Fiber — OPTICAL INTEGRITY, INC.
- Optical Integrity Laser Fiber — OPTICAL INTEGRITY, INC.
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
- Optical Integrity, Inc.
Sources (1)
- FDA UDI cb1888d9-6345-4445-8065-8c85698728a9 37 fields · synced May 30, 2026