Shield, Eye, Ophthalmic

Q: What is the product code of K945351?

The FDA product code is HOY – Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear), a Class I (low risk) device regulated under 21 CFR 886.4750.

FDA 510(k) K945351 · Taiwan Eva Industrial Co., Inc.

Substantially Equivalent

510(k) numberK945351

Submission

Device name: Shield, Eye, Ophthalmic
Applicant: Taiwan Eva Industrial Co., Inc.
Kaohsiung, TW
Received: September 14, 1994
Decision date: December 13, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: HOY – Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device class: Class I (low risk)
Regulation: 21 CFR 886.4750
Specialty: Ophthalmic

Other 510(k)s with product code HOY

510(k)	Device	Applicant	Decision
K132042	AMB101 System, Amblyz, LCG System, XpandHOY · Traditional	X6d, Ltd.	04/28/2014SE
K050856	LCG (Liquide Crystal Glasses) SystemHOY · Traditional	Ophthocare , Ltd.	05/31/2005SE
K971465	National Medical Halthcare Custom Ophthalmic Kits or TraysHOY · Traditional	National Healthcare Mfg. Corp.	06/04/1997SE
K944700	Arctic Premier SeriesHOY · Traditional	Sungold Eyewear, Inc.	12/22/1994SE
K944857	Goggle SafeguardHOY · Traditional	Sellstrom Mfg. Co.	12/15/1994SE
K945346	Makrolon 2405 Goggles (Light and Dark)HOY · Traditional	Universal Massage & Tanning, Inc.	11/22/1994SE
K942407	Amcon Slip in Mydriatic SunglassesHOY · Traditional	Amcon Laboratories, Inc.	06/06/1994SE
K941829	Sun Filters/ShieldsHOY · Traditional	Klinger Eye Shields, Inc.	05/17/1994SE
K930347	Shaids Protective GlassesHOY · Traditional	Depuy, Inc.	04/29/1994SE
K940275	Universal Cushioned Polycarbonat Eye ShieldHOY · Traditional	P.J. Products, Inc.	03/24/1994SE

More from P.J. Products, Inc.

510(k)	Device	Decision
K952438	Sunglasses (Non-Prescription Including Photosensitive)HQY · Traditional	09/12/1995SE
K945350	Frame, SpectaclesHQZ · Traditional	12/13/1994SE

Questions and answers

When was Shield, Eye, Ophthalmic cleared by the FDA?

Shield, Eye, Ophthalmic (K945351) received a 510(k) decision of Substantially Equivalent on December 13, 1994, 90 days after the submission was received.

What is the product code of K945351?

The FDA product code is HOY – Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear), a Class I (low risk) device regulated under 21 CFR 886.4750.