Suturegroove
by Iop, Inc.
510(k) K994289
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK994289 | Date17 Apr 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MML
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5700
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Suturegroove Eyelid Weight is an external eyelid weight designed for ophthalmic use. Classified as a Weights, Eyelid, External under FDA nomenclature, this device is intended to apply downward pressure to the upper eyelid, aiding in conditions such as ptosis or eyelid lag. Constructed from materials including gold, tantalum, platinum, iridium, or surgical-grade stainless steel, it provides mechanical support to improve eyelid function.
Suturegroove Eyelid Weights are supplied as a reusable, non-sterile set (K003646) and are regulated under FDA product code MML as a Class 2 Ophthalmic device. They are cleared via the Traditional 510(k) pathway and must be handled in accordance with sterile surgical protocols when implanted. Sizing sets include multiple weight variants for customization, and their use is restricted to trained ophthalmic professionals in clinical settings. No MRI safety information is specified, and storage should follow manufacturer guidelines for metallic implants.