510(k) clearances

Intense Pulsed Light System (ST-690)

Smedtrum Medical Technology Co., Ltd. · General, Plastic Surgery

K240482Substantially EquivalentTraditionalONF
Open FDA's page for this record
Third party flag
N
City
New Taipei City
Advisory committee description
General, Plastic Surgery
Address 1
1f., # 8, Ln. 97, Wugong Rd., Xinzhuang Dist.
Statement or summary
Summary
Product code
ONF
Zip code
248016
Applicant
Smedtrum Medical Technology Co., Ltd.
Decision date
2024-05-17
Decision code
SESE
Country code
TW
Device name
Intense Pulsed Light System (ST-690)
Advisory committee
SU
Contact
Crimson Wu
K number
K240482
Date received
2024-02-20
Review advisory committee
SU
Postal code
248016
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3033844600, 9680762, 3010027944, 3025268687, 3007238544, 3016453004, 2031934, 3007085226, 3015452693, 3013494333, 3006985163, 3016661372, 1313525, 3007120647, 3043657394, 3033482500, 3023281259, 8040564, 3005855240, 3006555617, 3011964664, 3017200975, 3010912900, 3003542872, 3016170453, 3030230686, 3006580954, 3033891767, 3033793026, 3033715699, 3007084556, 3012772112, 3010273872, 3043140693, 3021011208, 3027605738, 3009488834, 3011782009, 3011670002, 3033273466 +60 more
FEI number
3033844600, 3010027944, 3025268687, 3007238544, 3016453004, 3001415984, 3007085226, 3015452693, 3013494333, 3006985163, 3016661372, 3007120647, 3043657394, 3033482500, 3023281259, 3005855240, 3006555617, 3011964664, 3017200975, 3010912900, 3003542872, 3016170453, 3030230686, 6137, 3006580954, 3033891767, 3033793026, 3033715699, 3007084556, 3012772112, 3002942014, 3010273872, 3043140693, 3021011208, 3027605738, 3009488834, 3011670002, 3033273466, 3004635398, 3042351542 +59 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.