Ellipse I2PL+/ELLIPSE MultiFlex+
FDA 510(k)Class II (US FDA 510(k))
by Ellipse A/S
Identifiers
- 510(k) Number
- K140670 FDA 510(k)
- FDA Product Code
- ONF 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 device is a Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, as defined in its device type and nomenclature. It is an intense pulsed light system designed for dermatological applications.
It is supplied as a reusable system intended for use in dermatology settings, including treatments for hair removal, vascular lesions, acne, and pigmented lesions. The device received FDA 510(k) clearance (K140670) on September 25, 2014, and is classified as a Class II medical device under regulation number 878.4810.
Frequently asked questions
What is the ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ used for?
The device is an intense pulsed light system designed for dermatological applications, specifically intended for treatments such as hair removal, vascular lesions, acne, and pigmented lesions in dermatology settings.
Is the ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ a reusable or single-use device?
The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance between treatments, as indicated in its description for dermatology settings.
What regulatory pathway was used for the ELLIPSE I2PL+/ELLIPSE MULTIFLEX+?
The device received FDA 510(k) clearance under submission K140670 on September 25, 2014, and is classified as a Class II medical device under regulation number 878.4810, based on a traditional submission found substantially equivalent.
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: Ellipse MultiFlex+, I2PL+, SPT+ Operator's Manual | Manualzz, ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ (K140670) — FDA 510 (k) | Innolitics, PDF Premarket Notification Truthful and Accurate Statement, ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ 510 (k) K140670 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140670 | Class II | Active |
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Manufacturer
- Manufacturer
- Ellipse A/S
Sources (1)
- FDA 510(k) K140670 24 fields · synced Sep 27, 2026