Nā Hoʻoponopono Hoʻomalu

 He aha kāu e ʻike ai e pili ana i nā lula phototherapy UVB

Hoʻoponopono ʻia nā mea lapaʻau ma Kanada e Health Canada's Therapeutic Products Directorate (TPD) a ma USA e ka Food & Drug Administration (US-FDA). Hoʻokaʻawale ʻia nā lāʻau lapaʻau i hoʻokahi o nā Papa 1 a 4, kahi o ka Papa 1 e hōʻike ana i ka pilikia haʻahaʻa, a ʻo ka Papa 4 ka pilikia kiʻekiʻe loa. Hoʻonohonoho ʻia nā huahana phototherapy Solarc/SolRx UVB ma ke ʻano he "Class 2" ma Kanada a me USA. Hoʻomaopopo: Hoʻohana ka US-FDA i nā huahelu romana ma mua o nā helu no kēia mau papa, no laila ma USA, ʻo nā polokalamu Solarc ka "Class II".

In Kanaka, Aia nā papa 2 i nā mana he nui, e like me: - Ka hoʻokō ʻana i ka Canadian Medical Device Regulations (CMDR) - Ka ʻae ʻana o ka mākeke ma o ka laikini mīkini mua a me ka makahiki - Mandatory ISO-13488 a i ʻole ISO-13485 Quality System a me ka 3 makahiki pili. nā hoʻoponopono ʻaoʻao, a me ka hōʻike ʻana i nā pilikia. Hiki ke loaʻa nā papa inoa laikini hāmeʻa no Solarc Systems ma ka pūnaewele Papa inoa Laikini Laikini o Health Canada ma: www.mdall.ca. Kaomi "Huli Laikini Hana", a hoʻohana i ka "Inoa Hui" (Solarc). ʻO kahi ʻē aʻe, e hele i ka ʻaoʻao home ʻo Health Canada's Medical Device.

palapala aie1: Ma Iulai-21-2008, ua hoʻohui ʻia ʻekolu Laikini Lapaʻau Lapaʻau Health Canada (12783,62700,69833) a Solarc i hoʻokahi laikini (12783). ʻO ka "La Puka Mua" no nā hāmeʻa a pau koe ka 1000‑Series i kēia manawa e kū nei ma Iulai-21-2008; ʻoiai ua laikini mua ʻia kēia mau mea hana ma Iune-16-2003 no 62700 (500‑Series) a me Dec-02-2005 no 69833 (100‑Series). E hoʻomaopopo hoʻi ua laikini mua ʻia ka 1000‑Series ma Feb-1993 e “Health and Welfare Canada” ma Accession #157340, ma mua o nā Hoʻoponopono Mea Lapaʻau hou o Canada o Mei 1998.

palapala aie2: Ua loaʻa i nā polokalamu UVB Solarc Systems (UVB-Narrowband a me UVB-Broadband) ka ʻae ʻana o Health Canada e hoʻohui i ka "Vitamin D Deficiency" i ka "Indications of Use" (nā kūlana olakino e hiki ke hoʻolaha ma ke kānāwai) ma Iulai 21, 2008 ka hoʻololi ʻana o ka Solarc no ka Laikini Pūnaewele ʻo Health Canada #12783.

palapala aie3: Ma Ianuali 05, 2011, ua loaʻa iā Solarc ka ʻae ʻana o Health Canada e hoʻohui i kā mākou ʻohana hāmeʻa 4, ʻo E‑Series, i kā mākou Laikini Pūnaewele ʻo Health Canada #12783. Hōʻike ʻia ʻo Solarc's Health Canada Medical Device License #12783 ma lalo o kēia ʻaoʻao pūnaewele.

I ka USA, Papa II (Papa 2) pili i na mana he nui, me:

- Ka hoʻokō ʻana i nā ʻāpana pili o ke Code of Federal Regulations (CFR)

- Ka ʻae ʻana o ka mākeke ma o ka noi 510 (k) mua a me ka hoʻoholo ʻana o ka like nui.

- Ka hoʻouna ʻana i nā hōʻike mua a me ka hoʻololi ʻana i nā huahana i ka Center for Devices and Radiological Health (CDRH)

- Ka papa inoa o nā mea hana (hoʻokahi no ke code huahana)

- Manaʻo "Nā Hana Hana Hana maikaʻi" (GMP).

- Pono e hōʻike i nā pilikia

ʻAʻole ʻae ka US-FDA i ka hoʻohana kūʻai ʻana o 510 (k) a i ʻole ʻike hoʻoponopono ʻē aʻe. Eia naʻe, hiki ke loaʻa ma ke kānāwai kēia ʻike mai ka Paena pūnaewele US-FDA/CDRH. Ma ka ʻaoʻao ʻākau, e kaomi i lalo i nā mea hana a me nā kumuwaiwai > Medical Device Databases, kahi e hiki ai iā ʻoe ke ʻimi i ka Premarket Notifications 510 (k)'s a me nā Papa inoa Pūnaewele. E ʻimi me ka hoʻohana ʻana i ka "Inoa Mea noi" (Solarc) a i ʻole "Inoa Owner/Operator" (Solarc).

E hoʻohana i kēia mau loulou i ka huli ʻikepili a ka FDA:

510(k) Huli Pūnaewele

Huli i ka papa inoa o nā lakohana

palapala aie1: (pili ia ʻAmelika wale nō)

I ka makahiki 2011 a me ka hoʻohana ʻana i ke kaʻina hana 510 (k) a ka FDA, ua hāʻule ʻo Solarc i kāna hoʻāʻo ʻana e kiʻi i ka "Vitamin D Deficiency" i hoʻohui ʻia i ka "Indications for Use" no ka mea ʻaʻohe mea like "predicate" (pre-existing), a loaʻa ka ʻae. ua koi ʻia kahi palapala noi "PMA" ʻae ʻia ʻo Premarket Approval. I ka USA, no laila ʻo Solarc aole ʻae ʻia e hoʻolaha i nā mea hana no ka "Vitamin D Deficiency"; a ma kahi wale no ka "Indications for Use" o psoriasis, vitiligo, a me eczema. Ma kēia pōʻaiapili, ua manaʻo ʻia ʻo "Vitamin D Deficiency" he hoʻohana "off-label", akā naʻe, hiki i ke kauka ke noi i ka ʻike e pili ana i ka hoʻohana ʻana i waho-label, a ua ʻae ʻia ke kauka e kākau i kahi ʻōlelo kuhikuhi no ka mea maʻi. e kiʻi i ka huahana. ʻIke ʻia kēia manaʻo ma ke ʻano he "hana o ka lāʻau lapaʻau", ʻo ia hoʻi, hiki i ke kauka ke kuhikuhi a lawelawe paha i kekahi huahana kūʻai aku ma ke kānāwai no ka hoʻohana ʻana i waho o ka lepili a lākou i manaʻo ai he mea maikaʻi loa ia no ka mea maʻi.

Kauka Lapaau

He koho ke kauka kauka no ka hoʻouna ʻana i nā helu ʻāina ʻo Kanada a me International, akā pono no ka hoʻouna ʻana i nā helu US. No ka 'ike hou aku, e 'olu'olu e hele i: Nā mea kuhikuhi.

No Kaleponi wale nō

Hiki i kēia huahana ke hōʻike iā ʻoe i ka antimony oxide, ka mea i ʻike ʻia e ka mokuʻāina o Kaleponi e hoʻoulu ai i ka maʻi kanesa, a me toluene, ka mea i ʻike ʻia e ka mokuʻāina o Kaleponi e hoʻopōʻino i ka hānau ʻana a i ʻole nā ​​​​pōʻino hānau hānau. No ka 'ike hou aku e hele i www.P65Warnings.ca.gov

Solarc Health Canada Laikini Mea Hana 12783 Hoʻololi i ka helu leka uila 2017 08 21 ʻaoʻao 001 Solarc Systems FDA