Inserter/remover Contact Lens

Device Code: 4327

Product Code(s): KYE

Device Classification Information

• Device Type ID: 4327
• Device Name: Inserter/remover Contact Lens
• Regulation Description: Contact Lens Inserter/remover.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Contact Lenses And Retinal Devices Branch (CLRD)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 886.5420 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KYE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 4327
• Device: Inserter/remover Contact Lens
• Product Code: KYE
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Contact Lens Inserter/remover.
• CFR Regulation Number: 886.5420 [🔎]

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