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U.S. Department of Health and Human Services

Product Classification

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Device unit, cryophthalmic
Regulation Description Cryophthalmic unit.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHPS
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 886.4170
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons