Sharplight Technologies, Ltd.

FDA Regulatory Profile

Sharplight Technologies, Ltd. appears in FDA public data with 0 recalls, 4 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent FDA inspection ended on Feb 14, 2019 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Dec 22, 2023.

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Summary

Total Recalls
0
510(k) Clearances
4
Inspections
2
Compliance Actions
1

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 14, 2019Rishon Le-Tsiyon, IsraelDevicesVoluntary Action Indicated (VAI)3009352034
Jun 13, 2013Rishon Le-Tsiyon, IsraelDevicesVoluntary Action Indicated (VAI)3009352034

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K233304Omnimax S3, Omnimax S4Dec 22, 2023
K173169Rapid FamilyNov 20, 2017
K111303DERMATOLOGICAL TREATMENT DEVICE FAMILYDec 21, 2011
K082876BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILYNov 10, 2008