Models 5, 8, 20, 20S Argon Ion Lasers - 20
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K912438 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
- 5 FDA 510(k)8 FDA 510(k)20 FDA 510(k)20s Argon Ion Lasers 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 Models 5, 8, 20, 20S Argon Ion Lasers are powered laser surgical instruments. These devices are designed to deliver laser energy for surgical applications.
This device is identified under FDA 510(k) clearance K912438. It is manufactured by HGM Medical Laser Systems, Inc. and is classified as a Class II powered laser surgical instrument.
Frequently asked questions
What is the primary function of the HGM Argon Ion Lasers?
The Models 5, 8, 20, and 20S are powered laser surgical instruments engineered to deliver laser energy specifically for surgical applications.
What is the regulatory status of these laser devices?
These devices are identified under FDA 510(k) clearance K912438, which confirms they have been determined to be substantially equivalent to legally marketed predicate devices.
How are these devices classified for clinical use?
The HGM Argon Ion Lasers are classified as Class II powered laser surgical instruments, falling under the product code GEX and associated with general and plastic surgery advisory committees.
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: MODELS 5,8,20,20S ARGON ION LASERS - Innolitics, K912438 FDA 510(k) - MODELS 5 | Hgm Medical Laser Systems, Inc., K912438 FDA 510(k) - MODELS 5 | Hgm Medical Laser Systems, Inc., MODELS 5,8,20,20S ARGON ION LASERS 510(k) K912438 - FDA.report, ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER (K871424) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K912438 | Class II | Active |
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Manufacturer
- Manufacturer
- Hgm Medical Laser Systems, Inc.
Sources (1)
- FDA 510(k) K912438 24 fields · synced Sep 21, 2026