Midi-Srs
510(k) K141046
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141046 | Date24 Dec 2014 | 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- Withdrawn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
- ONG
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The MiDi-SRS is a Powered Laser Surgical Instrument With Microbeam Fractional Output, designed for precise tissue ablation and resurfacing in surgical procedures. It delivers controlled fractional laser energy to promote skin remodeling, collagen stimulation, and wound healing while minimizing lateral thermal damage. This device is intended for use in dermatological and plastic surgery applications requiring fractional laser treatment.
The MiDi-SRS is supplied as a reusable, non-sterile instrument requiring sterilization prior to use. It is classified as a Class II medical device under FDA regulation 878.4810 and has received FDA 510(k) clearance (K141046) for substantial equivalence. The device is intended for use in controlled clinical settings, such as operating rooms or procedural suites, and must be handled in accordance with manufacturer guidelines to ensure proper sterilization and operational safety. No MRI safety information is specified.
Questions
AI-generated answers, 19 Sep 2026
Is the MiDi-SRS designed for single-use or can it be reused after sterilization?
The MiDi-SRS is a reusable device that requires sterilization prior to each use, as explicitly stated in its description. It is not intended for single-use and must be properly sterilized and maintained according to manufacturer guidelines to ensure safety and functionality.
What types of surgical procedures is the MiDi-SRS intended for, and why is it specifically useful in those settings?
The MiDi-SRS is designed for dermatological and plastic surgery applications requiring fractional laser treatment. It delivers controlled fractional laser energy to promote skin remodeling, collagen stimulation, and wound healing while minimizing lateral thermal damage, making it particularly useful for procedures like resurfacing and tissue ablation in controlled clinical settings such as operating rooms or procedural suites.
How should the MiDi-SRS be stored, and does it come pre-sterilized?
The MiDi-SRS is supplied as a non-sterile reusable instrument, meaning it does not come pre-sterilized. It must be sterilized before use, and storage should follow manufacturer guidelines to maintain its condition and ensure it remains ready for proper sterilization when needed.
What regulatory pathway was followed for FDA clearance of the MiDi-SRS, and what does this mean for its use?
The MiDi-SRS received FDA 510(k) clearance under the traditional pathway, with a clearance number of K141046. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the U.S. under the specified indications for dermatological and plastic surgery applications requiring fractional laser treatment, while adhering to manufacturer guidelines for safe and effective use.
Can the MiDi-SRS be used in environments where MRI scans are performed, or are there any safety concerns related to MRI?
The device description explicitly states that no MRI safety information is specified for the MiDi-SRS. This implies that its safety in MRI environments has not been evaluated or confirmed, so caution should be exercised when using or storing the device near MRI machines.