Identifiers
- 510(k) Number
- K181614 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 Sterling Supreme Diode Laser is a laser surgical instrument for use in general and plastic surgery and in dermatology. It is a diode laser device cleared through the FDA 510(k) process under product code GEX and regulation number 21 CFR 878.4810.
The device was submitted by CAO Group, Inc. and received FDA clearance on September 10, 2019, under k-number K181614. It is classified as a Class 2 medical device and is intended for surgical cutting applications as indicated in its authorization and specifications.
Frequently asked questions
What is the Sterling Supreme Diode Laser used for?
The Sterling Supreme Diode Laser is a laser surgical instrument intended for surgical cutting applications in general surgery, plastic surgery, and dermatology, as specified in its FDA 510(k) clearance under product code GEX and regulation 21 CFR 878.4810.
How was the Sterling Supreme Diode Laser authorized for market release?
The device received FDA clearance through the traditional 510(k) pathway on September 10, 2019, under k-number K181614, demonstrating substantial equivalence to a predicate device for its intended surgical cutting use.
Who manufactures the Sterling Supreme Diode Laser and where are they located?
The Sterling Supreme Diode Laser is manufactured by CAO Group, Inc., located at 4628 W. Skyhawk Dr., West Jordan, UT 84084, United States, as listed in the device’s FDA submission details.
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: Sterling Supreme Diode Laser, CAO Group, Sterling Supreme Diode Laser (K181614) — FDA 510(k) | Innolitics, Sterling Supreme Diode Laser (K171986) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181614 | Class II | Active |
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Manufacturer
- Manufacturer
- Cao Group, Inc.
Sources (1)
- FDA 510(k) K181614 24 fields · synced Sep 25, 2026