510(k) clearances

Philips Lumea IPL

Philips Consumer Lifestyle B.V. · General, Plastic Surgery

K243453Substantially EquivalentTraditionalOHT
Open FDA's page for this record
Third party flag
N
City
Drachten
Advisory committee description
General, Plastic Surgery
Address 1
Tussendiepen 4
Statement or summary
Statement
Product code
OHT
Zip code
9206 AD
Applicant
Philips Consumer Lifestyle B.V.
Decision date
2025-02-10
Decision code
SESE
Country code
NL
Device name
Philips Lumea IPL
Advisory committee
SU
Contact
Martijn Halbesma
K number
K243453
Date received
2024-11-07
Review advisory committee
SU
Postal code
9206 AD
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Light Based Over-The-Counter Hair Removal
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3010027944, 3043749884, 3007238544, 3021338880, 3012294783, 3038373471, 3031182672, 3015452693, 3013494333, 3022594978, 3017400436, 3036720861, 3018366453, 3029944286, 3039435282, 3043177840, 3043657394, 3026132991, 3029792043, 3014787341, 3023281259, 3015989868, 3014527840, 3011964664, 3010912900, 3010677917, 3015542362, 3017954802, 3014327421, 3023876598, 3011547157, 3006580954, 3021599225, 3026360847, 3033793026, 3031233197, 3038319732, 3033879491, 3010360273, 3027605738 +54 more
FEI number
3010027944, 3043749884, 3007238544, 3021338880, 3012294783, 3038373471, 3031182672, 3015452693, 3013494333, 3022594978, 3017400436, 3036720861, 3018366453, 3029944286, 3039435282, 3043177840, 3043657394, 3026132991, 3029792043, 3014787341, 3023281259, 3015989868, 3014527840, 3011964664, 3010912900, 3010677917, 3015542362, 3017954802, 3014327421, 3023876598, 3011547157, 3006580954, 3021599225, 3026360847, 3033793026, 3031233197, 3038319732, 3033879491, 3010360273, 3027605738 +53 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.