屈光手术激光研究性器械豁免（IDE）申请中通常提交的信息清单。美国食品药品监督管理局眼科器械咨询小组。 - Suppr | 超能文献

Checklist of information usually submitted in an investigational device exemption (IDE) application for refractive surgery lasers. Ophthalmic Devices Advisory Panel, Food and Drug Administration.

出版信息

J Refract Surg. 1997 Sep-Oct;13(6):579-88. doi: 10.3928/1081-597X-19970901-15.

DOI:10.3928/1081-597X-19970901-15

Abstract

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Checklist of information usually submitted in an investigational device exemption (IDE) application for refractive surgery lasers. Ophthalmic Devices Advisory Panel, Food and Drug Administration.屈光手术激光研究性器械豁免（IDE）申请中通常提交的信息清单。美国食品药品监督管理局眼科器械咨询小组。

J Refract Surg. 1997 Sep-Oct;13(6):579-88. doi: 10.3928/1081-597X-19970901-15.

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Home-made excimer lasers are operating today in the US--the rest of the country watches and waits.如今美国有自制的准分子激光器在运行，而该国其他地区则在观望和等待。

J Refract Surg. 1995 Sep-Oct;11(5):328. doi: 10.3928/1081-597X-19950901-03.

4

FDA takes on maker of "homemade" excimer lasers.美国食品药品监督管理局对“自制”准分子激光仪制造商采取行动。

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Aberration analyses needed for FDA evaluation of safety and effectiveness of wavefront-guided refractive surgical devices.FDA评估波前引导屈光手术设备安全性和有效性所需的像差分析。

J Refract Surg. 2003 Sep-Oct;19(5):S588-91. doi: 10.3928/1081-597X-20030901-16.

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Intense competition shapes PRK delivery market.激烈的竞争塑造了准分子激光原位角膜磨镶术（PRK）手术市场。

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Arch Ophthalmol. 1995 Jul;113(7):858-9. doi: 10.1001/archopht.1995.01100070032019.

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Draft clinical guidance for the preparation and contents of an Investigational Device Exemption (IDE) application for excimer laser devices used in ophthalmic surgery for myopic photorefractive keratectomy (PRK). Office of Device Evaluation, Division of Ophthalmic Devices, Food and Drug Administration.

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