Manufacturer registered with FDA
ProSomnus Sleep Technologies
Pleasanton, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 25
- 510(k) clearances
- 32020–2026
- Markets registered in
- 57 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name ProSomnus Sleep Technologies as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | ProSomnus Sleep Technologies | 3 clearances | 2020–2026 | Below |
| Canada | Health Canada | Registration holder | PROSOMNUS SLEEP TECHNOLOGIES | 2 | 2025–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ProSomnus Sleep Technologies | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | ProSomnus Sleep Technologies | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | ProSomnus Sleep Technologies | 1 | 2021–2021 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What ProSomnus Sleep Technologies currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | MicrO2 Sleep DeviceProsomnus [CA] Low Profile Sleep and snore Device with Compliance MonitoringProsomnus [IA] Sleep DeviceProsomnus [PH] Sleep and Snore DeviceProsomnus [PH] Sleep and Snore Device with Compliance MonitoringProsomnus CA Sleep and Snore DeviceProsomnus CA Sleep and snore Device with Compliance MonitoringProSomnus RPMO2 OSA DeviceProSomnus® EVO [PH] Sleep and Snore DeviceProSomnus® EVO [PH] Sleep and Snore Device with Patient Monitoring 2 moreProSomnus® EVO Sleep and Snore DeviceProSomnus® EVO Sleep and Snore Device with Patient Monitoring | 2016 |
| Sleep Appliances with Patient MonitoringPLC · Class 2 | — | Maker | MicrO2 Sleep Device with MicroRecorderProsomnus [CA] Low Profile Sleep and snore Device with Compliance MonitoringProsomnus [IA] Sleep Device with MicroRecorderProsomnus [PH] Sleep and Snore DeviceProsomnus [PH] Sleep and Snore Device with Compliance MonitoringProsomnus CA Sleep and Snore DeviceProsomnus CA Sleep and snore Device with Compliance MonitoringProSomnus RPMO2 OSA DeviceProSomnus® EVO Sleep and Snore DeviceProSomnus® EVO Sleep and Snore Device with Patient Monitoring | 2016 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | ProSomnus RPMO2 OSA DeviceProSomnus® EVO Sleep and Snore DeviceProSomnus® EVO Sleep and Snore Device with Patient Monitoring | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names ProSomnus Sleep Technologies as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Apr 2026 | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | PLC Sleep Appliances with Patient Monitoring |
| 6 Oct 2022 | K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring | LRK Anti-Snoring Device |
| 20 Nov 2020 | K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring | LRK Anti-Snoring Device |
Also lists devices cleared under other names
ProSomnus Sleep Technologies lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Microdental, Inc. (2), Prosomnous Sleep Technologies (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Nov 2017 | K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Prosomnous Sleep Technologies | PLC Sleep Appliances with Patient Monitoring |
| 7 Nov 2016 | K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | PLC Sleep Appliances with Patient Monitoring |
| 24 Jul 2014 | K133683 | MICR02 OSA DEVICE | Microdental, Inc. | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PROSOMNUS SLEEP TECHNOLOGIESFDA reg. 3013116677 | Pleasanton, CA, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053490). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.