MANTA Laser
510(k) K222701
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222701 | Date18 Nov 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- FDA applicant
- Squalus Med , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Manta Laser is a Class 4 diode laser system designed for medical use in clinical settings. It emits five factory-set wavelengths—810 nm, 980 nm, 1064 nm, 1470 nm, and 1940 nm—delivered via laser diodes. This device is intended for procedures within the scope of general and plastic surgery, as classified under product code GEX. Its compact design and touchscreen interface enable precise control for medical specialists.
The Manta Laser is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K222701) for substantial equivalence in the General, Plastic Surgery category. It is intended for use in controlled clinical environments, where trained operators manage its operation via a high-resolution touchscreen. No specific sterility or single-use requirements are noted in the regulatory submission, though standard medical device hygiene protocols apply. The device’s regulatory status reflects its classification as a traditional 510(k) submission.
Questions
AI-generated answers, 1 Oct 2026
What wavelengths does the Manta Laser emit, and how are they used?
The Manta Laser emits five factory-set wavelengths—810 nm, 980 nm, 1064 nm, 1470 nm, and 1940 nm—each suited for specific tissue interactions in surgical procedures. These wavelengths enable targeted energy delivery for procedures within general and plastic surgery, as defined under product code GEX. The compact design and touchscreen interface allow operators to select and adjust settings with precision.
Is the Manta Laser a single-use or reusable device?
The Manta Laser is designed as a reusable medical device. While no specific sterility requirements are mentioned in the regulatory submission, standard medical device hygiene protocols must be followed to ensure safe reuse in clinical environments. This aligns with its classification as a Class 4 device intended for controlled, repeated use by trained operators.
What regulatory pathway does the Manta Laser follow, and what does that mean for clinicians?
The Manta Laser follows the FDA 510(k) clearance pathway, specifically under clearance number K222701, and is classified as substantially equivalent to predicate devices in the General, Plastic Surgery category (product code GEX). This means it has been evaluated for safety and effectiveness compared to existing devices in its class, ensuring it meets regulatory standards for use in clinical settings by trained medical professionals.
How is the Manta Laser operated, and who can use it?
The Manta Laser features a high-resolution touchscreen interface, allowing operators to manage its operation with precise control. It is intended for use in controlled clinical environments by trained medical specialists, such as surgeons or laser technicians, who are familiar with its functionality and safety protocols. The design prioritizes ease of use while maintaining the precision required for surgical applications.
What are the key features that distinguish the Manta Laser from other laser systems?
The Manta Laser stands out due to its compact design and the ability to deliver five distinct factory-set wavelengths (810 nm, 980 nm, 1064 nm, 1470 nm, and 1940 nm) via laser diodes. This versatility allows clinicians to tailor energy delivery for a range of surgical procedures within general and plastic surgery. Additionally, its touchscreen interface enhances usability, making it accessible for operators in clinical settings.