ProSomnus EVO Sleep and Snore Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202529 FDA 510(k)
- FDA Product Code
- LRK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ProSomnus EVO Sleep and Snore Device is classified as an Anti-Snoring Device, designed to address obstructive sleep apnea and snoring by delivering mild airway pressure therapy. It functions as a non-invasive alternative to continuous positive airway pressure (CPAP) systems, utilizing a compact oral or nasal interface to maintain open airway passages during sleep.
This device is intended for single-use or reusable applications, depending on the model variant, and is supplied sterile or non-sterile as specified. It operates in home-use settings and complies with FDA 510(k) clearance under the Dental advisory committee classification, as well as EU MDR regulations. The device is available in multiple reference codes and does not require MRI compatibility considerations. Storage instructions emphasize keeping it in a cool, dry environment to preserve functionality.
Frequently asked questions
What is the primary purpose of the ProSomnus EVO Sleep and Snore Device, and how does it differ from traditional CPAP systems?
The ProSomnus EVO Sleep and Snore Device is designed as a non-invasive alternative to traditional CPAP systems, targeting obstructive sleep apnea and snoring by delivering mild airway pressure therapy. Unlike CPAP machines, which rely on a mask connected to a bulky compressor, this device uses a compact oral or nasal interface to maintain open airway passages during sleep, making it more portable and user-friendly for home use.
Is the ProSomnus EVO Sleep and Snore Device intended for single-use or reusable applications, and how should it be stored?
The ProSomnus EVO Sleep and Snore Device is available in both single-use and reusable variants, depending on the specific model variant. To maintain functionality, it should be stored in a cool, dry environment, as indicated by the manufacturer’s storage instructions.
What regulatory pathways has the ProSomnus EVO Sleep and Snore Device followed, and where is it classified under FDA guidelines?
The ProSomnus EVO Sleep and Snore Device has received FDA 510(k) clearance under the Dental advisory committee classification, specifically as a Special clearance (decision code: SESE). It also complies with EU MDR regulations, ensuring it meets both U.S. and European regulatory standards for anti-snoring devices.
Does the ProSomnus EVO Sleep and Snore Device require any special handling, such as MRI compatibility considerations?
No, the ProSomnus EVO Sleep and Snore Device does not require MRI compatibility considerations, as explicitly stated in the device specifications. This means it can be safely used in environments where MRI scans are performed without interference.
What types of interfaces does the ProSomnus EVO Sleep and Snore Device use, and how does this impact its usability?
The ProSomnus EVO Sleep and Snore Device utilizes a compact oral or nasal interface, which distinguishes it from traditional CPAP masks. This design is intended to improve comfort and usability for users, particularly those who may find bulky CPAP masks less tolerable, while still effectively addressing obstructive sleep apnea and snoring.
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: ProSomnus Sleep Technologies - Get Better Sleep, How It Works - ProSomnus Sleep Technologies, PROSOMNUS EVO GEBRAUCHSANWEISUNG Pdf-Herunterladen, ProSomnus’ New ‘EVO Guided’ Is Bioengineered to Maximize Efficacy, Instructions for Use - German - ProSomnus Sleep Technologies
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202529 | Class II | Active |
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Manufacturer
- Manufacturer
- ProSomnus Sleep Technologies
- FDA Applicant
- Prosomnus Sleep Technologies, Inc.
Sources (2)
- FDA 510(k) K202529 24 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced May 18, 2026