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Sponge, Eyelid Cleaning, Powered

Page Type
Product Code
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 and Plastic Surgery
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4820
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4820 Surgical instrument motors and accessories/attachments

§ 878.4820 Surgical instrument motors and accessories/attachments.

(a) Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, 2000]

Sponge, Eyelid Cleaning, Powered

Page Type
Product Code
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 and Plastic Surgery
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4820
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4820 Surgical instrument motors and accessories/attachments

§ 878.4820 Surgical instrument motors and accessories/attachments.

(a) Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, 2000]