Cutera Enlighten III Laser System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Cutera, Inc.
Identifiers
- 510(k) Number
- K160488 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 Cutera Enlighten III Laser System is a fractional laser device designed for non-ablative skin resurfacing and hair removal. It delivers controlled laser energy to the skin to stimulate collagen production, improve skin texture, and reduce pigmentation, while also targeting hair follicles for reduction.
This system is supplied as a reusable medical device intended for use in clinical settings, including dermatology and plastic surgery offices. It is not single-use and requires proper maintenance and sterilisation protocols as outlined in the manufacturer’s instructions. The device is authorised under FDA 510K clearance, MDD, and MDR, adhering to regulatory standards for laser-based skin treatments. No specific MRI safety information is provided in the specifications.
Frequently asked questions
Is the Cutera Enlighten III Laser System intended for use in home settings or only in clinical environments like dermatology offices?
The Cutera Enlighten III Laser System is explicitly designed for clinical use only, such as dermatology and plastic surgery offices. It is not approved for home or non-professional settings, as it requires specialized training, maintenance, and adherence to sterilization protocols to ensure patient safety and device performance.
How is the Cutera Enlighten III Laser System supplied, and is it single-use or reusable?
The device is supplied as a reusable medical system, meaning it is not single-use. It must be maintained, cleaned, and sterilized according to the manufacturer’s instructions to prevent cross-contamination and ensure reliable operation over multiple patient treatments.
What regulatory pathways does the Cutera Enlighten III Laser System follow, and which committees were involved in its approval?
The system was cleared through the FDA’s 510(k) pathway under the product code GEX (General, Plastic Surgery) and reviewed by the Skin and Urology (SU) Advisory Committee. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) for European markets.
Can the Cutera Enlighten III Laser System be used for patients who require MRI scans, or are there safety concerns?
The manufacturer does not provide specific MRI safety information for the Cutera Enlighten III Laser System. Clinicians should follow standard MRI safety protocols for laser devices and consult the device’s instructions for use to ensure compatibility with MRI environments, as laser components may pose risks in such settings.
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
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160488 | Class II | Active |
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Manufacturer
- Manufacturer
- Cutera, Inc.
Sources (2)
- FDA 510(k) K160488 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026