510(k) clearances

IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)

Shenzhen Ulike Smart Electronics Co., Ltd. · General, Plastic Surgery

K233887Substantially EquivalentSpecialOHT
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
General, Plastic Surgery
Address 1
810, Bldg. 1, Xunmei Science And Technology Plz., # 8
Address 2
Keyuan Rd., Science Park Community, Yuehai Sub-District
Statement or summary
Statement
Product code
OHT
Zip code
518000
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
Decision date
2024-01-22
Decision code
SESE
Country code
CN
Advisory committee
SU
Contact
Blue Fang
K number
K233887
Date received
2023-12-08
Review advisory committee
SU
Postal code
518000
Decision description
Substantially Equivalent
Clearance type
Special
Device name

IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)

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.