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SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO - M002-2a

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101306

by Fotona D.D.

Identifiers

510(k) Number
K101306 FDA 510(k)
FDA Product Code
GEX FDA 510(k)
Models / Variants
M021-4af FDA 510(k)
3 FDA 510(k)
M002-2a 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)

These devices are fractional laser systems designed for skin resurfacing and aesthetic treatments. The SP Dynamis and SP Spectro combine Er:YAG and Nd:YAG laser technologies, while the XS Dynamis and XP Dynamis leverage high-performance Er:YAG lasers for precise skin ablation. Each model delivers controlled energy absorption in water, the primary chromophore for skin resurfacing, enabling micron-level precision with minimal thermal damage. The XP Spectro and XS Spectro variants offer similar capabilities in a compact form factor.

The devices are supplied as reusable medical equipment and are intended for use in clinical settings such as dermatology clinics and plastic surgery offices. They require appropriate training for operation and adherence to sterile protocols where applicable. The SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, and XP Spectro (Models M021-4AF/3, M002-2A) hold FDA 510(k) clearance under Product Code GEX, classified under Subpart E—Surgical Devices. Storage and maintenance must follow manufacturer guidelines to ensure optimal performance and safety.

Frequently asked questions

What are the SP Dynamis and SP Spectro fractional laser systems primarily used for?

The SP Dynamis and SP Spectro are designed for skin resurfacing and aesthetic treatments. They combine Er:YAG and Nd:YAG laser technologies to deliver controlled energy absorption in water, the primary chromophore for skin, enabling precise micron-level ablation with minimal thermal damage. This makes them ideal for procedures like texture improvement, scar revision, and pigmentation correction in dermatology and plastic surgery settings.

How are the XS Dynamis and XP Dynamis different from the SP models?

The XS Dynamis and XP Dynamis focus on high-performance Er:YAG lasers, offering precise skin ablation in a targeted manner. Unlike the SP models—which combine Er:YAG and Nd:YAG—they emphasize Er:YAG’s efficiency for controlled tissue removal. The XP Spectro and XS Spectro further refine this with a compact form factor, maintaining the same precision while optimizing space in clinical environments.

Are these devices single-use or reusable, and what sterility considerations apply?

These fractional laser systems are reusable medical equipment, intended for clinical settings like dermatology clinics and plastic surgery offices. Since they are reusable, they must be maintained per manufacturer guidelines to ensure sterility and performance. Sterile protocols (e.g., disinfection between patients) are critical, as they are not single-use devices.

What models are included in this FDA-cleared series, and how do they differ?

The series includes SP Dynamis (M021-4AF/3), SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, and XP Spectro (M002-2A). The key distinction lies in their laser configurations: SP models combine Er:YAG and Nd:YAG, while XS/XP variants emphasize Er:YAG precision. The XP Spectro and XS Spectro are compact versions of their counterparts, maintaining identical clinical capabilities in a smaller footprint.

What regulatory pathway does this device follow, and what does FDA clearance under Product Code GEX entail?

These devices hold FDA 510(k) clearance under Product Code GEX, classified under Subpart E—Surgical Devices. The clearance is based on a determination of substantial equivalence to a predicate device, meaning they share the same intended use and technological characteristics. The advisory committee (SU—General, Plastic Surgery) reviewed them for safety and effectiveness in fractional skin resurfacing 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: Sp Dynamis, Sp Spectro, Xs Dynamis, Xs Spectro, Xp Dynamis, Xp Spectro ..., SP Dynamis - Fotona, XS Dynamis - Fotona, SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fotona D.D.

Sources (1)

  • FDA 510(k) K101306 24 fields · synced Oct 1, 2026