| Device |
sponge, eyelid cleaning, powered |
| Regulation Description |
Surgical instrument motors and accessories/attachments. |
| Definition |
This device type is intended to cleanse the eyelid margins and eyelashes by a healthcare professional. |
| Physical State |
The eyelid cleaning device is a handheld device that spins a soft micro-sponge in the horizontal axis. The handpiece is made out of stainless steel and plastic, and the micro-sponge is composed of polyvinyl alcohol. The handpiece works with a lithium-ion battery and is charged in a plastic charging station. The battery-operated handpiece spins the medical grade micro-sponge (that has been soaked in foam) at 2,500 rpm along the lower and upper eyelid margins and eyelashes. The eyelid cleaning product is used with a commercially available eyelid cleansing foam. The micro-sponge is disposable; one sponge is used to clean each individual eyelid. |
| Technical Method |
The eyelid cleaning device is a device that cleanses the eyelid margins using a medical grade micro-sponge and eyelid cleansing foam. The micro-sponge is applied to the lower and upper eyelid margins and eyelashes to remove debris. A healthcare professional applies firm pressure to the eyelid margin in a variable, scrubbing swirling motion from nasal to temporal and back to the meibomian glands. The procedure lasts about 6-8 minutes and is gentle on the eyelid. |
| Target Area |
The target area is the eyelid margins. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
Ophthalmic |
|---|
| Product Code | PYU |
|---|
| Premarket Review |
Ophthalmic Devices
(DHT1A)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
878.4820
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
