Powered Eye Wash
510(k) K893829
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893829 | Date14 Nov 1989 | 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- Withdrawn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
- MSI
- Device Class
- Class III
- Advisory Committee
- Unknown
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is an Artificial Eye Solution, Cleaning/Lubricating (Product Code MSI), designed to irrigate and flush the eye under pressure to remove foreign particles or irritants. It falls under the FDA’s Class III device classification and is intended for use in ophthalmic procedures requiring controlled irrigation.
The Powered Eye Wash is supplied as a reusable system and requires connection to a sterile saline or irrigation fluid source for operation. It is intended for use in clinical settings, such as hospitals or ophthalmology clinics, and must be maintained per manufacturer instructions to ensure proper functionality. The device holds an FDA 510(k) clearance (K893829) under the Traditional pathway, granted in 1989, and is not explicitly noted for MRI compatibility or single-use constraints.
Questions
AI-generated answers, 18 Sep 2026
How is the Powered Eye Wash intended to be used in clinical settings and what type of fluid does it require?
The Powered Eye Wash is designed to irrigate and flush the eye under controlled pressure, helping remove foreign particles or irritants during ophthalmic procedures. It operates by connecting to a sterile saline or irrigation fluid source, meaning it relies on external fluid supply rather than containing its own solution. This makes it suitable for use in hospitals or ophthalmology clinics where sterile irrigation is standard.
Is the Powered Eye Wash meant for single-use or can it be reused in a clinical environment?
The Powered Eye Wash is explicitly described as a reusable system, meaning it is intended for repeated use in clinical settings. However, proper maintenance and cleaning per manufacturer instructions are required to ensure functionality and safety between uses. There is no mention of single-use constraints in the provided data.
What types of sizes or models are available for the Powered Eye Wash, and how is it typically supplied?
The provided data does not specify exact sizes or model variations for the Powered Eye Wash, but it is supplied as a reusable system requiring connection to an external sterile saline or irrigation fluid source. The device is designed for controlled irrigation in ophthalmic procedures, so its primary function dictates its use rather than varying physical configurations.
Does the Powered Eye Wash come pre-sterilized, or is sterilization handled separately before use?
The Powered Eye Wash itself is not described as pre-sterilized in the data, but it is intended for use with sterile saline or irrigation fluid. Since it is reusable, proper sterilization of the device between uses would be required as part of clinical protocols, though the exact sterilization method is not detailed. The focus is on maintaining functionality and cleanliness per manufacturer guidelines.
What regulatory pathway was followed for the FDA clearance of the Powered Eye Wash, and when was it granted?
The Powered Eye Wash received FDA clearance under the Traditional 510(k) pathway, specifically with clearance number K893829. This clearance was granted on November 14, 1989, and it was determined to be substantially equivalent to a predicate device. The device falls under Class III classification, which typically requires stringent regulatory oversight.