Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- HJFMagnifier, Hand-Held, Low-Vision1Product Code
- HJGSystem, Reading, Television, Closed-Circuit1Product Code
- HJHLoupe, Binocular, Low Power1Product Code
- HJXReader, Prism, Ophthalmic1Product Code
- HJYReader, Bar, Ophthalmic1Product Code
- HJZCrutch, Ptosis1Product Code
- HKBTelescope, Hand-Held, Low-Vision1Product Code
- HKCSpectacle Microscope, Low-Vision1Product Code
- HKKTelescope, Spectacle, Low-Vision1Product Code
- HOISpectacle, Magnifying1Product Code
- HOTAid, Vision Image Intensification1Product Code
- HPEAid, Vision, Optical, Battery-Powered1Product Code
- HPFAid, Vision, Electronic, Ac-Powered1Product Code
- HPGAid, Vision, Electronic, Battery-Powered1Product Code
- HPIAid, Vision, Optical, Ac-Powered1Product Code
- HQDLens, Contact (Other Material) - Daily2Product Code
- K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses2Cleared 510(K)
- K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses2Cleared 510(K)
- K241571BostonSight® Specialty Lenses2Cleared 510(K)
- K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)2Cleared 510(K)
- K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K230910NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens2Cleared 510(K)
- K221768Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses2Cleared 510(K)
- K223394Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)2Cleared 510(K)
- K212631Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses2Cleared 510(K)
- K213880Custom Stable Rigid Gas Permeable Scleral Contact Lens2Cleared 510(K)
- K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K202860Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)2Cleared 510(K)
- K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K183167Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K183175BostonSight Scleral2Cleared 510(K)
- K182304Hyper GP (tisilfocon A) Daily Wear Contact Lens2Cleared 510(K)
- K181579eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K2Cleared 510(K)
- K180988Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens2Cleared 510(K)
- K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG2Cleared 510(K)
- K171575ENFLU 18 (enflufocon A) Daily Wear Contact Lens2Cleared 510(K)
- K172314Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)2Cleared 510(K)
- K171950Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)2Cleared 510(K)
- K171077HEXA100 (hexafocon A) Daily Wear Contact Lenses2Cleared 510(K)
- K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)2Cleared 510(K)
- K170001Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K170007Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K170335Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens2Cleared 510(K)
- K163254Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens2Cleared 510(K)
- K153714SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co2Cleared 510(K)
- K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses2Cleared 510(K)
- K160938SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens2Cleared 510(K)
- K161461BostonSight PD Prosthetic Device2Cleared 510(K)
- K152724EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES2Cleared 510(K)
- K153066BostonSight IC Corneal Lens, BostonSight IC Scleral Lens2Cleared 510(K)
- K142510UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens2Cleared 510(K)
- K120996FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN2Cleared 510(K)
- K113586SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS2Cleared 510(K)
- K103561MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K102154TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS2Cleared 510(K)
- K083921SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS2Cleared 510(K)
- K082799HDS HI 1.542Cleared 510(K)
- K081178OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES2Cleared 510(K)
- K081443MENICON Z RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K081034SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS2Cleared 510(K)
- K080193SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR2Cleared 510(K)
- K073184BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS2Cleared 510(K)
- K071266BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K071043BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES2Cleared 510(K)
- K070637FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES2Cleared 510(K)
- K070628OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.2Cleared 510(K)
- K062548MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES2Cleared 510(K)
- K061120SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES2Cleared 510(K)
- K060102SYNERGEYES PS HYBRID CONTACT LENS2Cleared 510(K)
- K052983FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES2Cleared 510(K)
- K053124BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES2Cleared 510(K)
- K052675SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS2Cleared 510(K)
- K052507TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K051035SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS2Cleared 510(K)
- K033599ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS2Cleared 510(K)
- K033594OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES2Cleared 510(K)
- K024164COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT2Cleared 510(K)
- P880098MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- K021752FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL2Cleared 510(K)
- K021977HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K022128BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K013646ROSE K POST GRAFT LENS2Cleared 510(K)
- K013310PVS BASIC 2; EPIC 22Cleared 510(K)
- K013762RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K020006DYNA INTRA-LIMBAL LENS2Cleared 510(K)
- K011945RIGID GAS PERMEABLE CONTACT LENS SOLUTION2Cleared 510(K)
- K010454THE ALBERTA LENS SM2, SULFOCON B2Cleared 510(K)
- K011914HYDRO2, HS-752Cleared 510(K)
- K003932BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY2Cleared 510(K)
- K002845PAFLUFOCON C AND E DAILY CONTACT LENS2Cleared 510(K)
- K002703O-PERM 302Cleared 510(K)
- K002025RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- P880098MENICON SF-P (TM)2PMA Approval
- K001960RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K000795RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K993586SPORTSIGHT GP2Cleared 510(K)
- K000233MENICON SF-P2Cleared 510(K)
- K000133MENICON Z2Cleared 510(K)
- K000485HYDRO2, HS-752Cleared 510(K)
- P860022BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)2PMA Approval
- K992787EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR2Cleared 510(K)
- K991781FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K991780FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C2Cleared 510(K)
- K984436PVS BASICS2Cleared 510(K)
- K990895OXYCON LENS2Cleared 510(K)
- K990264COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS2Cleared 510(K)
- K980197ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K980741BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)2Cleared 510(K)
- P860022ITAFLUOROFOCON A AND B2PMA Approval
- P860022IPAFLUOROFOCON A AND B2PMA Approval
- K974636FLOSI RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- P860022IPAFLUOROFOCON A AND B2PMA Approval
- P860022IPAFLUOROFOCON A AND B2PMA Approval
- P870024FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES2PMA Approval
- K972443MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K963744BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)2Cleared 510(K)
- K963512BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL2Cleared 510(K)
- K970698BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS2Cleared 510(K)
- K963010LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K962006MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K962934AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K960584NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY2Cleared 510(K)
- K955366TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS2Cleared 510(K)
- K955900NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR2Cleared 510(K)
- K954124O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- K952260OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)2Cleared 510(K)
- K952165TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS2Cleared 510(K)
- P860022BOSTON EQUALENS(R) AND BOSTON RXD(R)2PMA Approval
- P860022BOSTON EQUALENS(R) AND BOSTON RXD(R)2PMA Approval
- K945955ROSE K LENS2Cleared 510(K)
- K944223ACCUCON2Cleared 510(K)
- K941883CONTACT LENS2Cleared 510(K)
- K943784MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR2Cleared 510(K)
- K943177BOSTON(R) 7 - 30(ENFLUFOCON A)2Cleared 510(K)
- K942533NOVALENS/NOVAWET PERCEPTION AND VANGUARD2Cleared 510(K)
- K942365BOSTON VII2Cleared 510(K)
- K940277PAFLUFOCON A, B, C & D2Cleared 510(K)
- P880024N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P860022BOSTON(R) EQUALENS (R) SCLERAL CONTACT LENS DESIGN2PMA Approval
- P920045OP-3 (TM) RGP CONTACT LENS2PMA Approval
- P880024N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL2PMA Approval
- P860022BOSTON EQUALENS(R) AND BOSTON RXD(R)2PMA Approval
- P840055GAS PERMEABLE CONTACT LENSES2PMA Approval
- P840055RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)2PMA Approval
- P890044TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890072ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS2PMA Approval
- P870024FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS2PMA Approval
- P870024FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS2PMA Approval
- P890058NOVALENS (ROSILFOCON A)2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P870024FLUOROPERM 151 (PAFLUFOCON D) CLEAR & TINTS W/O UV2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS ADD FINISH LABS2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890072ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS2PMA Approval
- P860022BOSTON EQUALENS(R) AND BOSTON RXD(R)2PMA Approval
- P860022BOSTON EQUALENS(R) AND BOSTON RXD(R)2PMA Approval
- P890058NOVALENS (ROSILFOCON A)2PMA Approval
- P880035VISTACRYL 18(KOLFOCON A) 32(KOLFOCON B) RGP LENSES2PMA Approval
- P840055RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)2PMA Approval
- P870024FLUOROPERM 60 (PAFLUFOCON B) CONTACT LENS2PMA Approval
- P900001RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P840055RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)2PMA Approval
- P890044TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P890072ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS2PMA Approval
- P880035VISTACRYL 18(KOLFOCON A) 32(KOFOCON B) RGP LENSES2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P870024FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS2PMA Approval
- P840050OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS2PMA Approval
- P890058NOVALENS (ROSILFOCON A)2PMA Approval
- P870024FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890072ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS2PMA Approval
- P890044TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P890072ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS2PMA Approval
- P890044ADD RGP LENS FINISHING LABORATORIES.2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A,B,C )CLEAR & TINTS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS ADD FINISH LABS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A,B,C )VIOLET TINT2PMA Approval
- P900001RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P840055RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS ADD FINISH LABS2PMA Approval
- P900001RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P840055RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A,B,C )CLEAR & TINTS2PMA Approval
- P820056OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS2PMA Approval
- P860022BOSTON(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN2PMA Approval
- P840050OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS2PMA Approval
- P900001RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P890044ADD RGP LENS FINISHING LABORATORIES.2PMA Approval
- P890044ADD RGP LENS FINISHING LABORATORIES.2PMA Approval
- P860022BOSTON(R) EQUALENS (R) AND RXD (R) MANU./ DIST.2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890072ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS ADD FINISH LABS2PMA Approval
- P840050OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890044ADD RGP LENS FINISHING LABORATORIES.2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON C) RGP GRAY TINT2PMA Approval
- P820056OPTACRYL 60 (KOLFOCON A)RGP BROWN TINT2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890044ADD RGP LENS FINISHING LABORATORIES.2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P900001RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P860022BOSTON(R) RXD(TM)& EQUALENS (TM) MANU.& DISTRIB.2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A)ALTERNATE MANU.SITE2PMA Approval
- P820056OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS2PMA Approval
- P840050OCUSIL(R) (NEFOCON A) CONTACT LENSES2PMA Approval
- P820056OPTACRYL 60 (KOLFOCON A)RGP FINISHING LABS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A)ALTERNATE MANU.SITE2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A, B, AND C) CONTACT LENS2PMA Approval
- P860022BOSTON(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN2PMA Approval
- P880035OPTACRYL RIGID GAS PERMEABLE CONTACT LENS MATERIAL2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS2PMA Approval
- P880001FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890044ADD RGP LENS FINISHING LABORATORIES.2PMA Approval
- P890072ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS2PMA Approval
- P860022BOSTON(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P900001RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890044HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P860022BOSTON(R) EQUALENS(R) & BOSTON(R) RXD(TM)2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890044HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P890044HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P880041VALIDATION/GETINGE ETHYLENE OXIDE STERILIZER2PMA Approval
- P880001FLUOREX(TM) FLUSILFOCON) 700,500,300 RGP LENS2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P900001RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890044HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890072ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS2PMA Approval
- P890058NOVALENS (ROSILFOCON A)2PMA Approval
- P890044HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890072ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890058NOVALENS (ROSILFOCON A)2PMA Approval
- P890044HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P900001SGP II - F CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P860022BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS2PMA Approval
- P860022BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS2PMA Approval
- P890044HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890058NOVALENS (ROSILFOCON A)2PMA Approval
- P860022BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS2PMA Approval
- P890044HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P900001SGP II - F CONTACT LENS2PMA Approval
- P880001FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P860022BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890058NOVALENS (ROSILFOCON A)2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (ITAFLUOROFOCON A)CONTACT LENS2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P880001FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS2PMA Approval
- P890058NOVALENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890058NOVALENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890058NOVALENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (ITAFLUOROFOCON A)CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890058NOVALENS2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P890046O-PERM F60 RGP CONTACT LENS2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P890058NOVALENS2PMA Approval
- P8800018LUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P8800018LUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (ITAFLUOROFOCON A)CONTACT LENS2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P8800018LUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P880041MODEL UV44B INTRAOCULAR LENS2PMA Approval
- P890044TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P860022THE BOSTON EQUALENS (INAFLUOROFOCON) CONTACT LENS2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P860022THE BOSTON EQUALENS (INAFLUOROFOCON) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (INAFLUOROFOCON) CONTACT LENS2PMA Approval
- P870024FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS2PMA Approval
- P850038PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS2PMA Approval
- P840055RIGID GAS PERMEABLE CONTACT LENSES2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P850038PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P8800018LUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P850038PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P8800018LUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P850038PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P850038PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P850038PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P880001FLUOREX (TM) 600 (FLURSILFOCON A)2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P860022THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820074OPUS - III CONTACT LENSES2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P870024FLUOROPERM RGP CONTACT LENSES2PMA Approval
- P850038PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P850038PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 VIOLET CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840055SGP LENS(TM)2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL II BLUE2PMA Approval
- P840050OCUSIL(TM) CONTACT LENS2PMA Approval
- P820056OPTACRYL K2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820074OPUS - III CONTACT LENSES2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820074OPUS - III CONTACT LENSES2PMA Approval
- P820074OPUS - III CONTACT LENSES2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- K841163CONTACT LENS INSERTER/REMOVER2Cleared 510(K)
- K840115SWISS OPTICAL PRODUCTS-CONTACT CASE2Cleared 510(K)
- P820062PARAPERM O2 CLEAR & BLUE LENS2PMA Approval
- P820056OPTACRYL 60 - CLEAR2PMA Approval
- P820074OPUS - III CONTACT LENSES2PMA Approval
- P790010DANKER SILICONE LENS (DIMEFOCON-A)2PMA Approval
- N17878MESO(CELLULOSE ACETATE BUTYRATE) HARD CONTACT LENS2PMA Approval
- HQGLens, Spectacle, Non-Custom (Prescription)1Product Code
- HQYSunglasses (Non-Prescription Including Photosensitive)1Product Code
- HQZFrame, Spectacle1Product Code
- HRCSterilizer, Soft-Lens, Thermal, Battery-Powered2Product Code
- HRDSterilizer, Soft-Lens, Thermal, Ac-Powered2Product Code
- HRLUnit, Beta, Radiation, Ophthalmic2Product Code
- KYEInserter/Remover Contact Lens1Product Code
- LPLLenses, Soft Contact, Daily Wear2Product Code
- LPMLenses, Soft Contact, Extended Wear3Product Code
- LPNAccessories, Soft Lens Products2Product Code
- LRXCase, Contact Lens2Product Code
- LYLAccessories, Solution, Ultrasonic Cleaners For Lenses2Product Code
- MMLWeights, Eyelid, External2Product Code
- MRCProducts, Contact Lens Care, Rigid Gas Permeable2Product Code
- MUWLens, Contact (Orthokeratology)2Product Code
- MVNLens, Contact, (Disposable)2Product Code
- MWLLens, Contact (Rigid Gas Permeable), Extended Wear3Product Code
- MZDSystem, In-Office Tinting, Contact Lenses2Product Code
- NAILens, Prescription, Color Deficiency1Product Code
- NCBWeights, Eyelid, Implantable2Product Code
- NCZLens, Contact, For Color Vision Deficiency2Product Code
- NICLens, Contact, For Reading Discomfort2Product Code
- NJHLens, Spectacle (Prescription), For Reading Discomfort1Product Code
- NUULens, Contact, Orthokeratology, Overnight3Product Code
- ORZEyelid Thermal Pulsation System2Product Code
- PICOral Electronic Vision Aid2Product Code
- PLXTear Duct Occluder1Product Code
- PQJIntranasal Electrostimulation Device2Product Code
- QBRIntranasal Electrostimulation Device For Dry Eye Symptoms2Product Code
- QIUIntense Pulsed Light Device For Managing Dry Eye2Product Code
- QKVElectromechanical Tear Stimulator2Product Code
- QMMHydrophilic Re-Coating Solution2Product Code
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K170007
- 510(k) Type
- Traditional
- Applicant
- Acuity Polymers, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/31/2017
- Days to Decision
- 148 days
- Submission Type
- Summary