510(k) clearances

B`orze Inc Laser Family (Sorren/Adonis)

Borze, Inc. · General, Plastic Surgery

K263063Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Boise
Advisory committee description
General, Plastic Surgery
Address 1
950 W Bannock, Suite 1100, Boise, Id 83702 Usa
Statement or summary
Summary
Product code
GEX
Zip code
83702
Applicant
Borze, Inc.
Decision date
2026-10-30
Decision code
SESE
Country code
US
Device name
B`orze Inc Laser Family (Sorren/Adonis)
Advisory committee
SU
Contact
Rex Howard Frazier
K number
K263063
State
ID
Date received
2026-09-01
Review advisory committee
SU
Postal code
83702
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
3006985163, 3007731000, 3010027944, 3044175602, 2938071, 3017125161, 3001222017, 3003708273, 3009380063, 3006985208, 3012452798, 3010822033, 3042261306, 3016076698, 2134812, 3013121972, 2011068, 3007712511, 3011137372, 3034246188, 3009462521, 3011670002, 3017144492, 3004450661, 1032227, 3007085226, 3033715699, 3013404959, 3012294783, 1045254, 9611388, 3045892905, 3008776882, 3015392301, 3014310779, 1221543, 3015452693, 3044905918, 3012669557, 2032513 +453 more
FEI number
3006985163, 3007731000, 3010027944, 3044175602, 2938071, 3017125161, 3001222017, 3003708273, 3009380063, 3004143769, 3006985208, 3012452798, 3010822033, 3042261306, 3016076698, 3013121972, 2011068, 3007712511, 3000204219, 1000623228, 3008133910, 3034246188, 3007475226, 3009462521, 3011670002, 3017144492, 3004450661, 1032227, 3007085226, 3033715699, 3012294783, 1045254, 3045892905, 3008776882, 3015392301, 3014310779, 1221543, 3015452693, 3044905918, 3012669557 +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.