Model 20 Ky Krypton Yellow Laser
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K881940 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 20 Ky Krypton Yellow Laser is a krypton laser designed for surgical applications, emitting yellow light at a wavelength suitable for tissue coagulation and vascular procedures. Classified under product code GEX, it is intended for use in general and plastic surgery settings, providing precise laser energy for medical interventions.
This laser is supplied as a reusable medical device and has received FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to a predicate device. It is intended for use in controlled clinical environments and requires proper handling and maintenance as outlined in its regulatory submission. No additional sterility or MRI safety information is specified in the provided data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K881940 FDA 510(k) - MODEL 20 KY KRYPTON YELLOW LASER, MODEL 20 KY KRYPTON YELLOW LASER - fda.innolitics.com, PDF K881940 - Model 20 Ky Krypton Yellow Laser, Hgm Medical Laser Systems Inc FDA Filings, Endocoagulator Model 20 Laser & Accessories 510 (k) FDA Premarket ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K881940 | Class II | Active |
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Manufacturer
- Manufacturer
- Hgm Medical Laser Systems, Inc.
Sources (1)
- FDA 510(k) K881940 24 fields · synced Sep 19, 2026