510(k) clearances

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)

Boston Aesthetics, Inc. · General, Plastic Surgery

K241832Substantially EquivalentTraditionalGEI
Open FDA's page for this record
Third party flag
N
City
Wilmington
Advisory committee description
General, Plastic Surgery
Address 1
1521 Concord Pike, Suite 201
Statement or summary
Summary
Product code
GEI
Zip code
19803
Applicant
Boston Aesthetics, Inc.
Decision date
2025-02-13
Decision code
SESE
Country code
US
Device name
Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
Advisory committee
SU
Contact
Hongmei Cao
K number
K241832
State
DE
Date received
2024-06-25
Review advisory committee
SU
Postal code
19803
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
1051614, 3029972466, 3007593903, 3015497424, 3013247477, 3021192541, 1062741, 1720747, 8010273, 2518897, 3007728276, 1057358, 3028977843, 3003537036, 1000523114, 3002806603, 2029015, 3007535734, 3004601121, 3009555600, 9681129, 3016248634, 3011944170, 3006266622, 3007047889, 3008864603, 3014931612, 3006985163, 3005110411, 3011625895, 3004837686, 8043746, 3004111573, 3002808148, 3033589330, 3043226252, 3043532708, 3022626486, 3008911114, 3010400367 +832 more
FEI number
1051614, 3029972466, 3007593903, 3015497424, 3013247477, 3021192541, 1720747, 1000136191, 3007728276, 3001319476, 3028977843, 3003537036, 1000523114, 3002806603, 3004601121, 3007535734, 3009555600, 1000208624, 3006469671, 3016248634, 3008185830, 3011944170, 2523865, 3006266622, 3007047889, 3008864603, 3014931612, 3006985163, 3005110411, 3011625895, 3002806575, 3004837686, 3004111573, 3002808148, 3033589330, 3043226252, 1000116158, 3043532708, 1000640985, 3022626486 +832 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.