Kungani Kubaluleke Kakhulu Ukugunyazwa Kwe-FDA Kwemasks Yokwelapha Okukhanyayo Kwe-LED

Amamaski okwelapha ukukhanya kwe-LED ngamadivayisi agqokekayo akhipha ukukhanya kumaza wamaza athile aklanyelwe ukusebenzisana nesikhumba ezingeni lamaselula. Lawa maski ngokuvamile asebenzisa ama-LED abomvu noma aluhlaza okwesibhakabhaka, noma inhlanganisela yakho kokubili, ukukhomba ukukhathazeka okuhlukile kwesikhumba. Ukukhanya okubomvu kuvame ukusetshenziselwa ukukhuthaza ukukhiqizwa kwe-collagen nokuthuthukisa ukunwebeka kwesikhumba, kuyilapho ukukhanya okuluhlaza okwesibhakabhaka kuphumelela ekwelapheni induna ngokubulala amagciwane abangela izinduna.
Umgomo we-LED light therapy i-photobiomodulation (PBM), lapho amandla okukhanya amuncwa amangqamuzana esikhumba, okubangela izinguquko zamaselula. Le nqubo icutshungulwe kakhulu, kanti i-NASA iqale yahlola ama-LED okuvuselelwa kwamaseli ngawo-1990. Kusukela ngaleso sikhathi, imishini yezinga lezokwelapha iye yasetshenziswa odokotela besikhumba iminyaka eminingi. Kodwa-ke, imaski yasekhaya ibilokhu isemakethe yezitolo cishe iminyaka emihlanu, futhi imvamisa inamandla amancane kunozakwabo abangochwepheshe. Noma kunjalo, isimiso sisafana: Ukwelashwa kokukhanya kwe-LED kungabangela izinguquko ezinhle esikhumbeni.

Kusho ukuthini Ukuvunyelwa kwe-FDA kubathengi

I-Food and Drug Administration (FDA) idlala indima ebalulekile ekuqinisekiseni ukuthi izinto zezokwelapha nemikhiqizo yezimonyo ziphephile futhi ziyasebenza kubathengi. Inqubo yokugunyaza ye-FDA ibandakanya ukuhlola okuqinile nokuhlola ukuze kutholwe ukuthi umkhiqizo uyahlangabezana na nezindinganiso eziqinile zokuphepha nokusebenza. Kumaski okwelapha ukukhanya kwe-LED, lokhu kusho ukuthi uma umkhiqizo uthole imvume ye-FDA, uhlolwe kakhulu ukuze ufakazele ukuphepha nokusebenza kwawo.
UDkt. Jonathan Kentley, udokotela wesikhumba ongumeluleki, uyachaza, I-FDA ilawula ukuphuma kwamandla, ubude begagasi, nobude besikhathi sokuchayeka ekukhanyeni ukuze kuqinisekiswe ukuthi idivayisi ayidali monakalo esikhumbeni. Lo mthetho ubalulekile ekuphepheni kwabathengi, ikakhulukazi ngokuthandwa okwandayo kwamadivayisi we-LED asekhaya.

Ukuphepha kanye nokusebenza ngempumelelo kwamamaski e-LED Light Therapy

Ngaphezu kwalokho, inqubo yokugunyaza i-FDA iqinisekisa ukuthi lawa madivayisi avivinywa ngokuqinile ukuthi ayasebenza yini. Lokhu kusho ukuthi izinkampani kufanele zinikeze idatha yomtholampilo ukuze zisekele izimangalo zazo. Isibonelo, uhlolo olubanzi lomtholampilo olwenziwa yinkampani iLuminaDerm lukhombise ukuthi imaski yabo ye-LED ingathuthukisa ukuthungwa kwesikhumba ngo-90% ngemuva kwamasonto ayisishiyagalombili yokusetshenziswa. Ucwaningo lwezokwelapha lungabonisa ukuthi amathuluzi angakwazi ukwelapha ngempumelelo izimo zesikhumba ezihlukahlukene, njengezinduna, imigqa emihle, nokulimala kwelanga.

Amazinga Okulawula kanye Nezimfuneko

Ngaphambi kokuthi imaski yokwelapha ukukhanya kwe-LED ithengiswe e-United States, kufanele ihlangabezane nezindinganiso ezithile zokulawula ezibekwe yi-FDA. Lawa mazinga ahlanganisa izici ezifana nobukhulu bokukhanya, ubude besikhathi sokuchayeka, kanye nokwakheka kwemaski ngokwayo. I-FDA idinga ukuthi abakhiqizi banikeze ulwazi oluningiliziwe mayelana nomkhiqizo, okuhlanganisa ukusetshenziswa kwawo okuhlosiwe, izinto owenziwe ngazo, kanye nezingozi ezingaba khona.
Izidingo zokulawula ziphinde zigunyaze ukuthi abakhiqizi banikeze idatha yomtholampilo ukuze basekele izimangalo zabo. Le datha kufanele ithunyelwe ku-FDA futhi ibuyekezwe ngokuqinile ukuze kuqinisekiswe ukuthi umkhiqizo uphephile futhi uyasebenza. Ngokunamathela kulawa mazinga, abakhiqizi bangathola ukugunyazwa kwe-FDA, okwakha ukwethenjwa kwabathengi nokuqinisekisa ukuthi umkhiqizo uhlangabezana nezindinganiso zekhwalithi ephezulu. Isibonelo, inkampani efana ne-SilkSkin kwadingeka inikeze idatha yomtholampilo ebanzi futhi ihlole imijikelezo eminingi ngaphambi kokuthi imaski yabo ithole imvume ye-FDA.

Izifundo Zemitholampilo kanye Nokuqinisekiswa Kwesayensi

Inqubo yokugunyaza i-FDA ayikona nje ukuthobela imithetho; imayelana nokuqinisekiswa kwesayensi. Izifundo zomtholampilo ezibalulekile zinikeze ubufakazi obanele obusekela ukusetshenziswa kwemaski yokwelapha ukukhanya kwe-LED. Isibonelo, ucwaningo olunzulu lwakamuva lwe-photobiomodulation (PBM) lugqamise isidingo sezivivinyo zomtholampilo ezengeziwe ezinosayizi abakhulu besampula ukuze kuqondwe ngokugcwele indlela yokwenza kanye nemingcele yokusetshenziswa efanele.
Ukwengeza, i-NASA yaqale yafunda ama-LED ngawo-1990 ukuze aqonde amandla awo okuvuselelwa kwamaseli. Kusukela ngaleso sikhathi, imishini yezinga lezokwelapha iye yasetshenziswa odokotela besikhumba iminyaka eminingi. Kodwa-ke, imaski yasekhaya ibilokhu isemakethe yezitolo cishe iminyaka emihlanu, futhi imvamisa inamandla amancane kunamadivayisi asezingeni lochwepheshe. Inqubo yokugunyaza ye-FDA iqinisekisa ukuthi lawa madivayisi aphephile futhi asebenza kahle njengozakwabo abangochwepheshe.

Imithelela Yemakethe Yabathengi Nabakhiqizi

Kubathengi, ukugunyazwa kwe-FDA kubalulekile ngoba kusho ukuthi umkhiqizo uhlolwe yinhlangano elawulayo ethembekile. Lokhu kuqinisekisa ukuthi idivayisi iphephile futhi iyasebenza, okungaba kubaluleke kakhulu kulabo abanokukhathazeka okuthile kwesikhumba noma izimo. Kubakhiqizi, ukuthola imvume ye-FDA kungathuthukisa isithunzi sabo nokwethembeka kwemakethe. Iphinde ivule amathuba amasha okusebenzelana nabahlinzeki bezempilo futhi ihlanganise imikhiqizo yabo ezinhlotsheni eziqeqeshiwe zokunakekelwa kwesikhumba.
Ikhasimende okuthiwa uSarah, obesebenzisa imaskhi yokwelapha ukukhanya kwe-LED egunyazwe yi-FDA izinyanga eziyisithupha, wabelane, nganginokungabaza ekuqaleni, kodwa imiphumela iye yaba isimanga. Imigqa yami emihle isithuthuke ngokuphawulekayo, futhi isikhumba sami sizizwa sithambile futhi sinamanzi amaningi.

Amathemba Esikhathi esizayo namathrendi kumamaski we-LED Light Therapy

Njengoba imakethe yemaski yokwelapha ukukhanya kwe-LED iqhubeka nokukhula, singalindela ukubona imikhiqizo emisha nobuchwepheshe. Amathrendi asafufusa ekwelapheni ukukhanya kwe-LED ahlanganisa ukuthuthukiswa kwezifihla-buso ezihlanganisa ubude bamaza obuningi bokwelashwa okuhlosiwe kokukhathazeka okuhlukene kwesikhumba. Ukwengeza, abakhiqizi bahlola ukuhlanganiswa kwezinye izindlela, njengokwelashwa kokudlidliza nezici zokupholisa, ukuze kuthuthukiswe ulwazi lomsebenzisi.
Isibonelo, inkampani eyodwa, i-GlowGenius, isivele ikhiphe imaski ehlanganisa ama-LED abomvu naluhlaza nokwelashwa kokudlidliza okuthambile. Inqubo yokugunyaza i-FDA iqinisekisa ukuthi lawa madivayisi awaphephile nje kuphela kodwa futhi ayasebenza, okuwenza abe isengezo esibalulekile kunoma iyiphi inqubo yokunakekelwa kwesikhumba.
Ukugunyazwa kwe-FDA kuzodlala indima ebalulekile ekubumbeni imakethe kanye nokusungula izinto ezintsha. Ngokuqinisekisa ukuthi imikhiqizo ihlangabezana namazinga aphezulu okuphepha nokusebenza kahle, i-FDA isiza ukugcina ukwethenjwa kwabathengi futhi ikhuthaze ukuqamba okusha okunesibopho. Njengoba ubuchwepheshe buthuthuka, singalindela ukubona imaski yokwelapha ukukhanya kwe-LED eyinkimbinkimbi futhi esebenza ngempumelelo enikeza izinzuzo zangempela kubathengi.
Sengiphetha, ukugunyazwa kwe-FDA kumamaski okwelapha ukukhanya kwe-LED kubalulekile ukuze kuqinisekiswe ukuphepha nokusebenza ngempumelelo kwalawa madivayisi. Inikeza abathengi isiqinisekiso sokuthi imikhiqizo abayisebenzisayo isekelwa ubufakazi besayensi namazinga okulawula aqinile. Njengoba imakethe iqhubeka nokukhula, ukugunyazwa kwe-FDA kuzohlala kuyisici esibalulekile ekuqhubekiseni ukuqanjwa kabusha kanye nokuletha imiphumela yangempela kubathengi.