Product Classification

• Device: unit, beta, radiation, ophthalmic
• Regulation Description: Ophthalmic beta radiation source.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: HRL
• Submission Type: 510(k)
• Regulation Number: 886.5100
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• tuv sud america inc.
• underwriters laboratories, inc.