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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aid, Vision, Electronic, Battery-Powered
510(k) Number K910124
FOIA Releasable 510(k) K910124
Device Name LOW VISION ENHANCEMENT SYSTEM (LVES)
Applicant
Triangle Investments
1629 Thames St.
3rd Floor
Baltimore,  MD  21231
Applicant Contact LEIGH R ABTS
Correspondent
Triangle Investments
1629 Thames St.
3rd Floor
Baltimore,  MD  21231
Correspondent Contact LEIGH R ABTS
Regulation Number886.5900
Classification Product Code
HPG  
Date Received01/11/1991
Decision Date 04/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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