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U.S. Department of Health and Human Services

Product Classification

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Device photocoagulator and accessories
Regulation Description Ophthalmic photocoagulator.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHQB
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 886.4690
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons