Exceed Microneedling Device
FDA 510(k)Class II (US FDA 510(k))
by MT.DERM GmbH
Identifiers
- 510(k) Number
- K180778 FDA 510(k)
- FDA Product Code
- QAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4430 FDA 510(k)
- Regulation Number
- 878.4430 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Exceed Microneedling Device is a powered microneedle device designed for controlled skin penetration. It falls under the category of devices used for dermatological procedures, specifically for creating microchannels in the skin to enhance treatment efficacy, such as for wrinkles or scarring.
This device is intended for professional use in clinical settings and is classified as a Class II medical device. It is supplied sterile for single-use applications and has received FDA 510(k) clearance under the registration number K180778. The device operates under the regulation number 878.4430 and is authorized for use in general plastic surgery procedures.
Frequently asked questions
What is the Exceed Microneedling Device used for?
The Exceed Microneedling Device is designed for controlled skin penetration to create microchannels, improving the delivery and efficacy of dermatological treatments. This is particularly useful for addressing wrinkles, scarring, or other skin imperfections by facilitating deeper absorption of topical agents or stimulating collagen production.
Is the Exceed Microneedling Device sterile and single-use?
Yes, the Exceed Microneedling Device is supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of cross-contamination in clinical settings, aligning with best practices for medical devices used in dermatological procedures.
What regulatory approval does the Exceed Microneedling Device hold?
The device has received FDA 510(k) clearance under the registration number K180778, confirming it meets regulatory standards for safety and effectiveness as a Class II medical device. It is authorized for use in general plastic surgery procedures under regulation number 878.4430.
How is the Exceed Microneedling Device supplied, and what should be considered for storage?
The device is supplied sterile and ready for immediate use in clinical settings. Since it is single-use, proper storage involves maintaining its sterile packaging until use. After opening, it should be used promptly to avoid contamination. Storage conditions should comply with manufacturer guidelines to preserve sterility and functionality.
Are there different models or sizes available for the Exceed Microneedling Device?
The provided data lists multiple FEI numbers associated with the Exceed Microneedling Device, which may correspond to different configurations or accessories. However, specific details on variations in microneedle length, depth settings, or other model-specific features would require direct consultation with the manufacturer, MT.DERM GmbH, for precise technical specifications.
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: EXCEED UNLIMITED | Medical Microneedling Device by Amiea med, ExCeed Microneedling, MT.DERM GmbH, K182407 FDA 510 (k) - Exceed Microneedling device | Mt. Derm GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180778 | Class II | Active |
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Manufacturer
- Manufacturer
- MT.DERM GmbH
- FDA Applicant
- Mt. Derm GmbH
Sources (1)
- FDA 510(k) K180778 24 fields · synced Oct 1, 2026