Identifiers
- 510(k) Number
- K181272 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 Picocare Family is a Powered Laser Surgical Instrument (Classification Name: 878.4810) designed for dermatological, surgical, and aesthetic procedures. It employs laser technology for precise tissue treatment, including applications in dermatology and plastic surgery.
This device is supplied as a reusable medical instrument and is classified under the FDA’s General and Plastic Surgery category (Product Code: GEX). It was cleared via the Special 510(k) pathway (K181272) as substantially equivalent to a predicate device, with no explicit sterility or MRI safety notes provided in the data. Storage and handling instructions are not specified in the regulatory submission.
Frequently asked questions
Is the Picocare Family designed for single-use or can it be reused after proper cleaning and sterilization?
The Picocare Family is explicitly described as a reusable medical instrument. Since it is classified under the FDA’s General and Plastic Surgery category (Product Code: GEX) and cleared via the Special 510(k) pathway, it is intended for repeated use in clinical settings. However, the regulatory submission does not specify sterilization methods or handling instructions, so users must follow manufacturer guidelines for reprocessing to ensure safety and efficacy.
What types of procedures is the Picocare Family primarily used for, and what makes it suitable for dermatological applications?
The Picocare Family is a Powered Laser Surgical Instrument designed for dermatological, surgical, and aesthetic procedures. Its laser technology enables precise tissue treatment, making it suitable for applications in dermatology and plastic surgery. The device’s classification under the FDA’s General and Plastic Surgery category (Product Code: GEX) reflects its intended use in controlled, specialized environments where laser precision is critical.
How is the Picocare Family supplied, and what should buyers consider regarding its storage and maintenance?
The Picocare Family is supplied as a reusable instrument, meaning it is intended for multiple uses in clinical settings. While the regulatory submission does not detail specific storage or handling instructions, buyers should follow the manufacturer’s guidelines to ensure proper maintenance, cleaning, and sterilization. Since it is classified under the FDA’s General and Plastic Surgery category, it must be stored and maintained in accordance with standard medical device protocols to preserve its performance and safety.
What regulatory pathway was used to clear the Picocare Family, and how does this affect its use in clinical settings?
The Picocare Family was cleared via the FDA’s Special 510(k) pathway (K181272), specifically under the General and Plastic Surgery category (Product Code: GEX). This pathway confirms that the device is substantially equivalent to a predicate device, meaning it meets FDA standards for safety and effectiveness in its intended applications. Clinicians can rely on this clearance to ensure the device adheres to regulatory requirements for powered laser instruments in dermatological and surgical procedures.
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: K181272 FDA 510 (k) - Picocare Family | Wontech Co., Ltd., 510(k) Premarket Notification - accessdata.fda.gov, Picocare Family (K181272) — FDA 510 (k) | Innolitics, Picocare Family 510 (k) K181272 - 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 | K181272 | Class II | Active |
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Manufacturer
- Manufacturer
- Wontech Co., Ltd
- FDA Applicant
- Wontech Co., Ltd.
Sources (1)
- FDA 510(k) K181272 24 fields · synced Sep 19, 2026