SENSILIGHT MINI

FDA 510(k) clearance K140527 · decided 2014-07-31

Clearance details

K-number: K140527
Device name: SENSILIGHT MINI
Applicant: El Global Trade, Ltd.
Decision: Substantially Equivalent
Date received: 2014-03-04
Decision date: 2014-07-31
Days to decision: 149 days
Clearance type: Traditional
Product code: OHT
Device class: 2
Regulation number: 878.4810
Medical specialty: General, Plastic Surgery
Advisory committee: General, Plastic Surgery
Location: Netanya, IL
Third-party review: No
Expedited review: No

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Recalls involving this device

No recalls on record reference this clearance.