Decision Date2019-03-18
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Sensilight Pro / Pistol IPL is the device name listed in this FDA 510(k) record. The listed applicant is El Global Trade, Ltd.. It received FDA 510(k) clearance on 2019-03-18 under 510(k) number K183260. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sensilight Pro / Pistol IPL?
Sensilight Pro / Pistol IPL is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is El Global Trade, Ltd.. The 510(k) number is K183260.
When did Sensilight Pro / Pistol IPL receive FDA 510(k) clearance?
Sensilight Pro / Pistol IPL received FDA 510(k) clearance on 2019-03-18, under 510(k) number K183260.
Who is the listed applicant for Sensilight Pro / Pistol IPL?
The FDA 510(k) record lists El Global Trade, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sensilight Pro / Pistol IPL?
The FDA product code for Sensilight Pro / Pistol IPL is OHT.
Other records listing El Global Trade, Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Related Devices (Code: OHT)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Official Source
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