510(k) clearances

SmartIPL_NI System

Lumenis Be, Ltd. · General, Plastic Surgery

K241973Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Yokneam Ilit
Advisory committee description
General, Plastic Surgery
Address 1
Hakidma St. 9, P.O.B 426
Statement or summary
Summary
Product code
GEX
Zip code
2069236
Applicant
Lumenis Be, Ltd.
Decision date
2026-09-19
Decision code
SESE
Country code
IL
Device name
SmartIPL_NI System
Advisory committee
SU
Contact
Shlomit Segman
K number
K241973
Date received
2024-07-05
Review advisory committee
SU
Postal code
2069236
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Powered Laser Surgical Instrument
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3005580113, 2125050, 3001431138, 3003288808, 3014384451, 3000313549, 3009736547, 3010359222, 1319639, 3006680097, 3048246437, 3004940677, 1222993, 3037047060, 3036240802, 3015077548, 3034246188, 1725006, 3011024620, 3009078366, 3016678045, 3005205318, 3011302631, 3027725665, 3007689729, 3043127589, 3017954802, 3010912900, 3030090167, 9610617, 3001605696, 1225450, 1221275, 3027605507, 3043657394, 3009298127, 3018116888, 3002808227, 3008156177, 3013789508 +453 more
FEI number
3005580113, 2125050, 3001431138, 3003288808, 3014384451, 3000313549, 3009736547, 3010359222, 3006680097, 3048246437, 3003465293, 3037047060, 3036240802, 3015077548, 3034246188, 3011024620, 3009078366, 3016678045, 3005205318, 3011302631, 3027725665, 3043127589, 3017954802, 3010912900, 3030090167, 3001605696, 1221275, 3027605507, 3043657394, 3009298127, 3018116888, 3002808227, 3013789508, 3015151147, 3002807715, 1000116142, 3021334828, 3007674911, 3002809599, 3002483854 +451 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.