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U.S. Department of Health and Human Services

Product Classification
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Device weights, eyelid, implantable
Regulation Description Eyelid weight.
Definition Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
Physical State An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye.
Technical Method It uses gravity/weight of the metal to assist in closure of the eyelid.
Target Area Eyelid
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNCB
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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