SIDE-FIRING UROLOGIC REFRACTIVE FIBER

Powered Laser Surgical Instrument

ENERGY LIFE SYSTEMS CORP.

The following data is part of a premarket notification filed by Energy Life Systems Corp. with the FDA for Side-firing Urologic Refractive Fiber.

Pre-market Notification Details

Device IDK943409
510k NumberK943409
Device Name:SIDE-FIRING UROLOGIC REFRACTIVE FIBER
ClassificationPowered Laser Surgical Instrument
Applicant ENERGY LIFE SYSTEMS CORP. 3303 HARBOR BLVD., UNIT D-13 Costa Mesa,  CA  92626
ContactHany Hussein
CorrespondentHany Hussein
ENERGY LIFE SYSTEMS CORP. 3303 HARBOR BLVD., UNIT D-13 Costa Mesa,  CA  92626
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-14
Decision Date1994-08-23

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