NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151473 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 NaturaLase PiQo4 is a Nd:Y AG 1064 Q-switched laser with a 532 nm accessory and Pulse Slicing Module. This device is designed for use in medical procedures requiring laser technology. It operates at a wavelength of 1064 nm with an optional 532 nm accessory and includes a Pulse Slicing Module for enhanced functionality.
The device is supplied by Focus Medical, LLC and has received FDA 510K clearance with the product code GEX. It is intended for use in general and plastic surgery applications. The device is not specified as single-use or reusable, and no information regarding MRI safety, sterility, or storage conditions is provided in the data.
Frequently asked questions
What is the NaturaLase PiQo4 laser system used for?
The NaturaLase PiQo4 is designed for use in medical procedures requiring laser technology, specifically in general and plastic surgery applications. It operates at a wavelength of 1064 nm with an optional 532 nm accessory and includes a Pulse Slicing Module for enhanced functionality.
Is the NaturaLase PiQo4 a single-use or reusable device?
The device data does not specify whether the NaturaLase PiQo4 is designed for single-use or multiple reuse. This information would need to be confirmed with the manufacturer, Focus Medical, LLC, as it is not provided in the available documentation.
What regulatory approvals has the NaturaLase PiQo4 received?
The NaturaLase PiQo4 has received FDA 510K clearance with the product code GEX. It was determined to be substantially equivalent to predicate devices and is intended for general and plastic surgery applications, as reviewed by the General and Plastic Surgery advisory committee.
What are the key components of the NaturaLase PiQo4 system?
The NaturaLase PiQo4 system includes a Nd:Y AG 1064 Q-switched laser with an optional 532 nm accessory and a Pulse Slicing Module. These components work together to provide enhanced functionality for various medical procedures requiring laser technology.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151473 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Focus Medical, LLC
Sources (1)
- FDA 510(k) K151473 24 fields · synced Oct 6, 2026