Injector, Capsular Tension Ring

Device Code: 4369

Product Code(s): NCE

Device Classification Information

• Device Type ID: 4369
• Device Name: Injector, Capsular Tension Ring
• Regulation Description: Intraocular Lens Guide.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• 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)
• CFR Regulation Number: 886.4300 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: NCE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 10-78 ISO 11979-3 Third Edition 2012-12-01
  Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties And Test Methods

Total Product Life Cycle

• Device Type ID: 4369
• Device: Injector, Capsular Tension Ring
• Product Code: NCE
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Intraocular Lens Guide.
• CFR Regulation Number: 886.4300 [🔎]

TPLC Last Update: 2019-04-02 20:47:52