HOYA OPTICAL LABS OF AMERICA, INC.

FDA Device Registration & Listing · Ramsey, MN, US · Registration 2124545

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2124545
FEI Number
2124545
Entity Name
HOYA OPTICAL LABS OF AMERICA, INC.
City/State/Country
Ramsey, MN, US
Establishment Address
7000 Sunwood Dr NW, Ramsey, MN 55303, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Hoya Optical Labs of America, Inc. (Owner Number: 8030208)
Owner / Operator Contact Address
651 E. Corporate Dr, Lewisville, TX 75057, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SYNC III BKS LensChoice HUREN AF 2 Sharpsight LC WORKHD P ARRAY II Wrap 17 MR-174/174 iD MyStyle 2 Adventure LC MEDIA III 9 Infinity Nulux ARRAY II 13 P-1W 1.67 14 DC SF Seiko Super MV LC ELITE4 HD D ID Lifestyle 4 Indoor ID Lifestyle 2 Harmony cd PL 1.67 DC Infinity Digital SSV DC SF Easy Clean Plus/ECP FX2 11 LC ELITE PRE PBSP 15 AMPIA LC ELITE2C HD S Desire LC ELITE4 HD B PC WIDE PROCEED II Super Clean Coat/SCC ASPHERIC-SV (NULUX) LensChoice Photo Quick PROMINENT iD MyStyle 2 Lens Choice Elite Short Lifestyle 4 SUN Polarized Urban PX ALL FOCUS PRO SURMOUNT Innocare Blue ARRAY Wrap 11 ISIGHT SUCCEED WS 13 FX3 10 iD MyStyle 2 Stable Nulux Plastic lens 1.67 Perfas LC ELITE2 BSP 11 HiVision EyeConnect SUPERCEDE II PX ENERGY III LC Elite Plus S Nulux Plastic lens 1.74 Hoyanet Standard PAL STRIVE HD LC ELITE3 HD B SYNC (NULUX ACTIVE/REMARK) S16 AR AF MINI THINDEX D-R DFx LC MEDIA III 5 GP (Finished) iD MyStyle 3 Adventure AR3 LC ELITE3 SUN D iD SV (NULUX-EP) Infitnity Desk iD MyStyle 2 Modern Lifestyle 3 SUN Polarized Outdoor Recharge Vision Ease Strippable HC ARRAY Non-Compensated 15 LC ELITE BSP 13 ULTRA THIN UV1.67 AR ECP Suntech ARRAY II VL Infinity Extreme FFSF 1.74 DC ASSURE HD PX ALL FOCUS P13 SUCCEED SHORT iD MyStyle 3 Modern OPTIMUM SHORT iD InStyle (HOYALUX ID) Meiryo iD MyStyle 3 Expert PX OFFICE SP NULUX ACTIVE 5 Spectangle Pro FX1 15 Innocare Plus Recharge Kids Infitnity HD3 Lifestyle 4 SUN Polarized Indoor SUCCEED Spectaclear AR FFSF1.67TOI Hilux Plastic lens 1.59 ARRAY Non-Compensated VL Eyvia 1.74 TACT Infinity SVB LC STD BSP 11 ID Lifestyle 4 Urban LC WORK3HD P ID Lifestyle 2 Harmony SSVAR SUPER CLEAN Elite NVP DIGITAL PolarTrue PRESTIGE WS SSV UV SF PENTAX ADVNTG Eyey 1.70 Surpass ECP AR ULTRA THIN UV1.60 ECP LC SV Plus P-1W 1.67 12 Super Hi Vision EX3 ISIGHT PLUS MINI Integrated Dual Surfaced Technology LC ELITE BSP 11 PL 1.60 UC LensChoice Photo Dark Hoya DF VELA AR Standard PAL Short P-1W 1.67 16 GP (Semi-Finished) FFSF1.60UC SUPER 16 DA LC ELITE PRE PBSP 13 Surpass AR Amplitude HD3 Spectangle LC ELITE2C HD MR-8/160 3D Binocular Vision Technology Amplitude iQ Infitnity HD3 S Nulux Plastic lens 1.59 EnRoute SV LITE UV 1.60 SF THC LC WORK3HD R LC MEDIA III 13 ID Lifestyle 3 Outdoor Amplitude Mini iQ EnRoute PAL SUMMIT ECP VISION- EASE S16 DC ID Lifestyle 2 LC ASV iD WorkSpace SRC GX-101 13 ARRAY 17 BluCut UV420 Super AR LC Elite SH BKS Tact Pro BKS Eyry PL 1.60 DC Lumacore TEGRA ARRAY Wrap 17 SHAR BluCut UV420 PL 1.74 DC PX ALLFOCUS FX S SUPERIOR B LC WORKHD R ARRAY 11 AVID HD DiaCoat HC FX4 14 HiVision ViewProtect FFSF1.67UC Super HiVision Meiryo EX4 ULTRA THIN UV1.60 THC SURMOUNT WS D-R DFx SHORT FFSF 1.67DC SF The Hoya Free Form Technology Sensity 3 iD WorkStyle 3 MR-10/167 Lifestyle 4 SUN Polarized Outdoor Sharpsight Short Infinity Mini Lifestyle 3 SUN Polarized Urban LC ELITE2H HD D-R TASK Innocare LC Elite Short TRUECHOICE XD S HVC Viewer INFINITY SVB HI SUCCEED WS 11 SPGAZ RX SCC Sensity SUCCEED 2 LC ELITE2 BSP 15 LC ELITE2 BSP 13 LC Elite ASCENT iD MyStyle 3 Detail TRUECHOICE XD ARRAY II 15 Distortion-Free Optics AVID Hyper Amenity Coat/HAMC Hilux Plastic lens 1.53 ID Lifestyle 3 ARRAY II Wrap 13 TACT BKS SUPER SV AR Elite Short LC ELITE3 HD D ID Lifestyle 4 Outdoor LIFERX LC ELITE3 HD N LC ELITE PRE PBSP 17 Phoenix LC STD PAL P Infitnity A+ Mini ARGOS SHORT LC SV ARRAY II 17 Accord FFSF 1.60 DC SF LC ELITE2 BSP 17 ID Lifestyle 2 cd ARRAY 13 FX3 12 Stable View Enhancer LC COMPU 60 LC ELITE3 SUN N AMPIA HD SHORT PROPRIUS DH GX-301 12 PX ALLFOCUS S Amplitude HiDef iD LifeStyle (HOYALUX FD) SV iQ Amplitude Mini BKS PL 1.67 UC AF 2 MINI SUMMIT CD iQ SHAR ISIGHT MINI LC ELITE BSP VL LC WORK3HD N Sensity 2 ADVANTA ST28 iQ INFINITY SVB LOW LC STD PAL ALLIANCE Infinity A+ P-1W 1.67 14 Yuniku iD MyStyle 3 LensChoice Photo 2 ULTRA THIN UV1.67 THC PENTAX DIGIX 13 Phoenix 1.53 Plastic Lens PREMIER 2 Diamond Clear UJ1.60 SF Sun PX OFFICE DP LC ELITE PRE PBSP 11 LC Elite Plus SUPERIOR F Amplitude Poly Lens LC ELITE4 SUN D SUPERNAL Clear Away Esteem FX3 14 LC ELITE4 SUN N SSV DC Super Durable Coat/SDC NULUX ACTIVE 8 PNX Kids UltraView Plus LC STD PAL P S INFINITY SVB MID ID Lifestyle 3 Indoor PX ALL FOCUS P11 D-R APEX LC Elite BKS Eynoa 1.67 SUPERIOR N Fogless Coat/FLC HMC Ultra (coating) AF ARRAY II Wrap 15 Nulux Plastic lens 1.60 AMPIA SHORT HOYALUX NuPolar SUNRX HEV LC ELITE PRE PBSP VL Amplitude iD MyStyle 3 Tyro PROTECTINT Hoyalinc LC SV COMP PROCEED III FX4 10 Amplitude HD3 Mini VIVID AR Sensity Dark FFSF1.67TR Eyas 1.60 2 Hoya Clear Blue Filter VE Photo HOYA Identifier ARRAY II 11 SV (HILUX) PX ALL FOCUS P15 ARRAY Wrap VL ID Lifestyle 3 Urban ID Lifestyle 2 Clarity cd Super Hi Vision EX3+ OUTLOOK PENTAX ADVNTG 11 CONTINUA PENTAX SV HD LC ELITE BSP 15 ClearMax Integrated Dual Sided Technology VELA SHAR AR LC ELITE2H HD S Lifestyle 3 SUN Polarized Indoor VISION-EASE Clear Blue Filter BKS Technology HM1 (coating) Aspect Hilux Plastic lens 1.50 Sensity Original Eyas 1.60 Ultra AR iD Space, Screen, Zoom P-1W 1.67 12 DC SF iD WorkSmart LC MEDIA 5 ActV ISIGHT HD MINI ARRAY Wrap 13 ARRAY 15 iD WorkStyle 3 Space FX4 12 ARRAY II Wrap VL AdaptEase Technology ARRAY Non-Compensated 11 iD MyStyle 2 Detail LC STD BSP 15 Super Hi Vision (SHV) ARRAY II Wrap 11 LC ELITE2 BSP VL PhotoActiv SUNRX ID Lifestyle 2 Clarity View Xpansion Technology LC WORKHD N Premium PAL GX-301 14 SUMMIT ecp iQ (Summit TF) PENTAX DIGIX 11 PENTAX DIGIX UltraView ST28 GP Wide D-R APEX MINI ISIGHT HD Aurora GX-301 16 iD LifeStyle cd (HOYALUX FD) LC ELITE BSP 17 PRESTIGE 2 WS Stabilight Technology ARRAY Non-Compensated 13 FX2 13 Amplitude Mini HiDef SUMMIT CD SuperClean AR LC ELITE4 SUN B PROPRIUS DS PREMIER iD WorkStyle V+ HMC+ (coating) PX ALLFOCUS FX Binocular Harmonization Technology ARRAY Wrap 15 Super Registance Coat/SRC PX ALLFOCUS MySV Hoya Diamond int ARRAY VL HMO (coating) LC ELITE3 SUN B LC COMPU 40 PolarThin PX ENERGY I ACSCENT HD LC MEDIA 8 iD WorkStyle 3 Zoom Infitnity Office LC ELITE4 HD N Sensity Fast LensChoice Photo 3 PENTAX DIGIX 15 ARRAY Non-Compensated 17 FX1 13 SV identity V+ LC STD PAL S Super HyDro AR Lens Choice Elite ID Lifestyle 4 iD WorkStyle 3 Screen HMC (coating) OPTIMUM HM2 (coating) FFSF 1.60TOI LC ST28 Binocular Eye Model PENTAX ADVNTG 15 Seiko Super SV ISIGHT PLUS AMPIA HD LensChoice Photo SunSport Amplitude BKS iD MyStyle Materialise Frame

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQG Lens, Spectacle, Non-Custom (Prescription) Ophthalmic Class 1 886.5844 2002-02-28
HQZ Frame, Spectacle Ophthalmic Class 1 886.5842 1978-06-14

Official Correspondent

Evelyn Stewart

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hoya Optical Labs of America, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005693266 HOYA VISION CARE - CLEVELAND BEREA, OH, US
3003367816 P.T. VISION EASE ASIA LIPPO CIKARANG-BEKASI Jakarta, ID
3033777988 Hoya Vision Care Phoenix Tempe, AZ, US
3007581768 HOYA LENS VIETNAM LTD Binh Duong Ward, Ho Chi Minh, VN
3005502151 HOYA VISION CARE - LARGO LARGO, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K910951 United Optical, Spa OPTHLAMIC FRAMES 1991-05-06

Similar Registrations

Registration Number Establishment Name Location
3006755718 DONGGUAN YUEHENG OPTICAL CO. LTD. Dongguan Guangdong, CN
3015534032 BOLLE SAFETY INC Carlsbad, CA, US
3007675955 Carl Zeiss Vision Canada, Inc. Toronto Ontario, CA
1000428458 GKB OPHTHALMICS LIMITED - UNIT II North Goa Goa, IN
3038136215 MEIVISION (VIETNAM) CO., LTD Ho Chi Minh City, VN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2124545. Last updated year: 2026. Please use registration number 2124545 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.