misight有fda 认证,ok没有。但ok技术很成熟了,如果你家小朋友年纪小睡眠质量好,建议ok.
brewhaha 发表于 2023-06-01 01:10
OK镜2002 年6月就被FDA 批准了。https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P870024S043 PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..Generic NameLens, contact, orthokeratology, overnight Date06/13/2002
Approval Order Statement APPROVAL FOR THE FOLLOWING DEVICES AND INDICATIONS: THE PARAGON CRT (PAFLUFOCON B) AND PARAGON CRT 100 (PAGLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES FOR CORNEAL REFRACTIVE THERAPY ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN A CONTACT LENSES CORNEAL REFRACTIVE THERAPY FITTING PROGRAM FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 6.00 DIOPTERS IN EYES WITH ASTIGMATISM UP TO 1.75 DIOPTERS. THE LENSES MAY BE DISINFECTED USING ONLY A CHEMICAL DISINFECTION SYSTEM. THE PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES FOR CORNEAL REFRACTIVE THERAPY ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN A CONTACT LENS CORNEAL REFRACTIVE THERAPY FITTING PROGRAM FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 3.00 DIOPTERS IN EYES WITH ASTIGMATISM UP TO 1.50 DIOPTERS. THE LENSES MAY BE DISINFECTED USING ONLY A CHEMICAL DISINFECTION SYSTEM. NOTE: TO MAINTAIN THE CONTACT LENS CORNEAL REFRACTIVE THERAPY EFFECT OF MYOPIA REDUCTION OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE. FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.Approval OrderApproval OrderSummarySummary of Safety and EffectivenessLabelingLabeling Labeling Part 2