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Pico Shining (Pico-K; Picofy)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K261214

by Speclipse, Inc.

Identifiers

510(k) Number
K261214 FDA 510(k)
FDA Product Code
GEX FDA 510(k)
Models / Variants
Pico Shining (pico-K FDA 510(k)EUDAMED
Picofy) FDA 510(k)EUDAMED

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 Pico Shining is a pico-second laser device designed for non-ablative skin resurfacing and fractional photothermolysis. It delivers controlled energy pulses to stimulate collagen production, improve skin texture, and address mild to moderate photoaging, pigmentation, and vascular lesions. The system operates using picosecond laser technology to target specific skin layers without disrupting the epidermis.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as dermatology clinics or plastic surgery offices. It is classified under the General, Plastic Surgery advisory committee category and requires adherence to standard laser safety protocols. The Pico Shining is authorized under FDA 510K and MDD regulations, with a clearance type designated as Special. Sterility and maintenance protocols must follow manufacturer guidelines to ensure safe, repeated use.

Frequently asked questions

What types of skin concerns can the Pico Shining address, and how does its technology differ from traditional laser treatments?

The Pico Shining is specifically designed for non-ablative skin resurfacing and fractional photothermolysis, targeting mild to moderate photoaging, pigmentation issues, and vascular lesions. Unlike traditional laser treatments that may disrupt the epidermis, this device uses picosecond laser technology to deliver controlled energy pulses deep into the skin, stimulating collagen production and improving texture without damaging the surface layer. This makes it ideal for patients seeking rejuvenation with minimal downtime.

Is the Pico Shining a single-use device, or is it intended for repeated clinical use? What maintenance is required?

The Pico Shining is a reusable medical instrument intended for use in clinical settings like dermatology clinics or plastic surgery offices. Since it is reusable, it must be maintained and sterilized according to the manufacturer’s guidelines to ensure safe, repeated use. Proper cleaning and adherence to laser safety protocols are critical to prevent contamination and maintain performance.

What regulatory pathways does the Pico Shining follow, and how does its classification impact its use?

The Pico Shining is authorized under both FDA 510K and MDD (Medical Device Directive) regulations, with a clearance type designated as Special. It falls under the General, Plastic Surgery advisory committee category (GEX product code), meaning it is classified as a substantially equivalent device. This classification ensures it meets safety and effectiveness standards for non-ablative skin treatments, but clinicians must still follow manufacturer instructions and laser safety protocols during use.

Are there different models or configurations available for the Pico Shining, and if so, how do they differ?

The device data lists multiple address lines (#501 through #505 and 232), which likely correspond to different models or configurations of the Pico Shining system (e.g., PICO-K or PICOFY). While the exact specifications of each variant aren’t detailed here, these distinctions may relate to wavelength settings, energy outputs, or additional features tailored for specific skin concerns. Clinicians should consult the manufacturer’s documentation for precise differences between models.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Speclipse, Inc.

Sources (2)

  • FDA 510(k) K261214 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026