Compac A, Elite A, Elite A Plus, Surgica A
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K913569 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)
This device is a powered laser surgical instrument classified under product code GEX. It is designed for use in general and plastic surgery procedures.
The device was cleared via the FDA 510(k) pathway under K913569 with a traditional clearance type and a substantially equivalent decision. It is manufactured by Hgm Medical Laser Systems, Inc. and is intended for use in clinical settings as a powered laser surgical instrument.
Frequently asked questions
What is the COMPAC A, ELITE A, ELITE A PLUS, SURGICA A device used for?
This device is a powered laser surgical instrument designed for use in general and plastic surgery procedures, as indicated in its FDA 510(k) clearance documentation.
How was the COMPAC A, ELITE A, ELITE A PLUS, SURGICA A device cleared for market?
The device received FDA 510(k) clearance under K913569 through a traditional review process, resulting in a substantially equivalent decision based on its comparison to a legally marketed predicate device.
Who manufactures the COMPAC A, ELITE A, ELITE A PLUS, SURGICA A laser surgical instrument?
Hgm Medical Laser Systems, Inc. is the manufacturer of this device, as specified in the FDA 510(k) submission and authorization records.
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: K913569 FDA 510(k) - COMPAC A | Hgm Medical Laser Systems, Inc., COMPAC A, ELITE A, ELITE A PLUS, SURGICA A 510(k) K913569 - fda.report, PDF K913569 - Compac A, Elite A, Elite a Plus, Surgica A
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K913569 | Class II | Active |
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Manufacturer
- Manufacturer
- Hgm Medical Laser Systems, Inc.
Sources (1)
- FDA 510(k) K913569 24 fields · synced Sep 27, 2026