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Softrans Injector

FDA 510(k)

Class III (US FDA 510(k))

510(k) K913626

by Staar Surgical Co.

Identifiers

510(k) Number
K913626 FDA 510(k)
FDA Product Code
HQL FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 886.3600 FDA 510(k)
Regulation Number
886.3600 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SoftTrans Injector is a device classified as an intraocular lens injector, designed to facilitate the precise delivery of intraocular lenses (IOLs) into the eye during cataract surgery. It ensures controlled insertion with minimal manipulation, reducing potential trauma to the lens or surrounding tissues.

This single-use, sterile device is intended for use in ophthalmic surgical settings and is regulated under FDA 510(k) clearance (K913626) as substantially equivalent to predicate devices. Supplied in a sterile, pre-packaged configuration, it adheres to Class III medical device standards and is compatible with MRI environments. No reusable components or additional sterilization steps are required.

Frequently asked questions

What is the primary purpose of the SoftTrans Injector in cataract surgery?

The SoftTrans Injector is designed specifically to deliver intraocular lenses (IOLs) into the eye during cataract surgery with precision and minimal manipulation. This reduces the risk of trauma to the lens or surrounding tissues, ensuring smoother and safer IOL placement.

Is the SoftTrans Injector reusable, or is it intended for single-use only?

The SoftTrans Injector is explicitly labeled as a single-use device. It comes pre-packaged and sterile, eliminating the need for additional sterilization or reuse, which helps maintain safety and hygiene in surgical settings.

How is the SoftTrans Injector packaged, and what does this imply for its use?

The SoftTrans Injector is supplied in a sterile, pre-packaged configuration, meaning it is ready for immediate use without requiring further preparation. This ensures sterility and reduces the risk of contamination before surgery.

Can the SoftTrans Injector be used in environments where MRI scans are performed?

Yes, the SoftTrans Injector is explicitly stated to be compatible with MRI environments. This makes it suitable for use in facilities where patients may undergo MRI scans post-surgery without interference.

What regulatory pathway was followed for the SoftTrans Injector’s approval, and what does this mean for its use?

The SoftTrans Injector was cleared through the FDA’s 510(k) pathway, specifically under the traditional review process, and is classified as substantially equivalent to predicate devices. This means it meets FDA standards for safety and effectiveness as determined by comparative analysis with existing approved devices, ensuring its compliance for use in ophthalmic surgical settings.

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

United States Active

FDA_510K

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Manufacturer

Manufacturer
Staar Surgical Co.

Sources (1)

  • FDA 510(k) K913626 24 fields · synced Sep 18, 2026