510(k) clearances

Single Use CO2 Laser Fiber (HAF005001)

Quanta System Spa · General, Plastic Surgery

K243588Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Samarate
Advisory committee description
General, Plastic Surgery
Address 1
Via Acquedotto 109
Statement or summary
Summary
Product code
GEX
Zip code
21017
Applicant
Quanta System Spa
Decision date
2025-02-19
Decision code
SESE
Country code
IT
Device name
Single Use CO2 Laser Fiber (HAF005001)
Advisory committee
SU
Contact
Dario Bandiera
K number
K243588
Date received
2024-11-20
Review advisory committee
SU
Postal code
21017
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
3017144492, 3038356864, 3016096097, 3017786046, 3043153468, 3007156625, 1000523114, 3002806603, 3012294783, 3007535734, 2031934, 3033126947, 3019252665, 2521877, 1226005, 3004497289, 3006985163, 3003610527, 3030979014, 9710340, 1424785, 3026400760, 3004111573, 3006786907, 3044175602, 2032092, 3016830208, 3010822033, 2027755, 3003288808, 3011050570, 3016170453, 3014577013, 3005282635, 3027605646, 3016413636, 3042261306, 3008085016, 3006580954, 3010363436 +453 more
FEI number
3017144492, 3038356864, 3016096097, 3017786046, 3043153468, 1000623228, 1000523114, 3002806603, 3012294783, 3007535734, 3033126947, 3019252665, 2521877, 3004497289, 3006985163, 3003610527, 3030979014, 3026400760, 3003559308, 3004111573, 3006786907, 3044175602, 3016830208, 3010822033, 2027755, 3003288808, 3011050570, 3016170453, 3014577013, 3005282635, 3027605646, 3016413636, 3042261306, 3008085016, 3006580954, 3010363436, 3001362763, 2938889, 3042953831, 3004361445 +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.