Suntouch Eye Spear
by HuiZhou Foryou Medical Devices Co., LTD.
510(k) K132796
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK132796 | Date30 Oct 2013 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- HOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4790
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Suntoch Eye Spear is an ophthalmic surgical instrument designed for precise tissue manipulation during eye procedures. Classified as a Class II device under FDA regulations, it is intended for use in delicate ocular surgeries where controlled penetration and dissection are required, such as cataract surgery or vitrectomy.
Supplied sterile and intended for single-use, the device is manufactured by HuiZhou Foryou Medical Devices Co., Ltd. It adheres to FDA 510K and MDR authorisations, with a clearance type designated as Traditional. The instrument is non-magnetic and suitable for use in non-MRI environments. Storage should follow manufacturer guidelines to maintain sterility and functionality.
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Questions
AI-generated answers, 18 Sep 2026
What types of eye surgeries is the Suntouch Eye Spear designed for, and how does it assist in those procedures?
The Suntouch Eye Spear is specifically designed for delicate ocular surgeries where precise tissue manipulation is required, such as cataract surgery or vitrectomy. It provides controlled penetration and dissection, allowing surgeons to navigate sensitive eye structures with accuracy during these procedures.
Is the Suntouch Eye Spear intended for reuse, or is it meant to be used only once?
The Suntouch Eye Spear is supplied sterile and explicitly intended for single-use only. This ensures patient safety and maintains sterility standards for each surgical procedure.
Can the Suntouch Eye Spear be used in an MRI environment, or is it restricted to non-MRI settings?
The Suntouch Eye Spear is non-magnetic, but it is explicitly stated as suitable only for use in non-MRI environments. This means it should not be used in procedures involving MRI machines.
How should the Suntouch Eye Spear be stored to ensure it remains functional and sterile?
The manufacturer recommends following their storage guidelines to maintain both sterility and functionality. While specific instructions aren’t detailed in the data, standard practices for single-use surgical instruments—such as keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight—should be followed.
What regulatory pathways has the Suntouch Eye Spear undergone, and what does that mean for its use?
The Suntouch Eye Spear has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, both classified under Traditional clearance types. This means it has been reviewed and deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended ophthalmic applications.