2035, Inc.
US Last updated 23 May 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Qlaser System Ref K080513
What 2035, Inc. makes
2035, Inc. manufactures the QLASER System, a medical device designed for laser-based procedures in clinical settings.
The QLASER System is classified as a Class II device under FDA regulations and is listed in the 510(k) registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does 2035, Inc. manufacture?
2035, Inc. specializes in the QLASER System, a medical device intended for laser-based clinical procedures. The device is designed to perform specific therapeutic or diagnostic tasks in regulated healthcare environments.
Where is 2035, Inc. based?
2035, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory jurisdiction and compliance framework, particularly under U.S. medical device laws.
How are the devices manufactured by 2035, Inc. classified under U.S. regulations?
The QLASER System from 2035, Inc. is classified as a Class II device under the U.S. Food and Drug Administration (FDA) regulations. This classification indicates moderate risk, requiring specific controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Are the devices from 2035, Inc. listed in any regulatory registries?
Yes, the QLASER System is listed in the FDA’s 510(k) registry. This registry includes devices that have undergone a premarket notification process, demonstrating that the manufacturer has determined their device is substantially equivalent to a legally marketed predicate device. Listing in this registry helps healthcare providers and regulators verify compliance and authorization status.
Information
- Country
- US