Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

Device Code: 4267

Product Code(s): HOY

Device Classification Information

• Device Type ID: 4267
• Device Name: Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
• Regulation Description: Ophthalmic Eye Shield.
• 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: 886.4750 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: HOY
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-282 ISO 12609-1 First Edition 2013-07-15
  Eyewear For Protection Against Intense Light Sources Used On Humans And Animals For Cosmetic And Medical Applications -- Part 1: Specification For Products
• 12-283 ISO 12609-2 First Edition 2013-07-15
  Eyewear For Protection Against Intense Light Sources Used On Humans And Animals For Cosmetic And Medical Applications -- Part 2: Guidance For Use

Total Product Life Cycle

• Device Type ID: 4267
• Device: Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
• Product Code: HOY
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Ophthalmic Eye Shield.
• CFR Regulation Number: 886.4750 [🔎]

Premarket Reviews
Manufacturer	Decision
X6D, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:45:48