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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameimplant, corneal, refractive
Generic Nameimplant, corneal, refractive
820 oak creek drive
lombard, IL 60148
HDE NumberH040002
Date Received03/03/2004
Decision Date07/26/2004
Product Code
LQE[ Registered Establishments with LQE ]
Docket Number 06M-0233
Notice Date 06/09/2006
Advisory Committee Ophthalmic
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the intacs® prescription inserts for keratoconus. This device is indicated for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for a comeal transplant procedure may potentially be deferred. The specific subset of keratoconic patients proposed to be treated with intacs prescription inserts arethose patients: 1) who have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; 2) who are 21 years of age or older; 3) who have clear central comeas; 4) who have a comeal thickness of 450 microns or greater at the proposed incision site; and 5) who have comeal transplantation as the only remaining option to improve their functional vision.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S003 S004