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Enova Illumination

Enova Illumination, Inc. · Model 90092-004 · UDI-DI 00810186670313

510(k) clearances

Adverse events

Recalls

Facilities

Description

Quasar Cool Deluxe LED Headlight System Contains the following items, by Enova part number and UDI: Part Name Part No. UDI Quasar Cool lamp 80088 00850025993487 Carrying Case 80034-001 00850025993678 PP4 80201-001 00850025993616 Black Extension Cable 80303-001 00850025993708 Battery Belt 80500-001 00850025993722 Base Station 80100-001 00850025993647 C-13 Power Cord (Type B)* 80150-001 00850025993739 C-13 Power Cord (Type C)* 80150-00C 00810186670214 C-13 Power Cord (Type G)* 80150-00G 00810186670139 C-13 Power Cord (Type I)* 80150-00I 00810186670207 *One power cord per system; style depends on region to which the unit is sold.

Recalls

Date	Firm	Reason
2014-06-11	Integra LifeSciences Corp.	LED battery chargers may prematurely fail and will not charge the LED battery as intended

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.