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PRECISION ENDOSCOPIC INFRARED COAGULATOR - Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide
FDA 510(k)Class II (US FDA 510(k))
510(k) K122593
by Optim Llc
Identifiers
- 510(k) Number
- K122593 FDA 510(k)
- FDA Product Code
- FEH FDA 510(k)
- Models / Variants
- Precision Endoscopic Infrared Coagulator FDA 510(k)Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide FDA 510(k)Model 5100-2 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4300 FDA 510(k)
- Regulation Number
- 876.4300 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
PRECISION ENDOSCOPIC INFRARED COAGULATOR - Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide by Optim Llc — Class II — FDA_510K — listed in FDA…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122593 | Class II | Active |
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Manufacturer
- Manufacturer
- Optim Llc
- FDA Applicant
- Optim, LLC
Sources (1)
- FDA 510(k) K122593 24 fields · synced Jun 18, 2026