FDA.reportPublic FDA data

Sterile Micro Needle ELLISYS ST

Primary DI
08809495930777
Brand
Sterile Micro Needle ELLISYS ST
Company
Chungwoo Co., Ltd.
Model
CWM-930S_ELLISYS ST-S25
Published
2024-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233120000CWM-930S, FIXER DV9Chungwoo Co., Ltd.2024-05-23GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809495930777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809495930777088094959307778809495930777

GMDN Terms#

Term, Definition table
TermDefinition
Resective skin contouring/liposuction system needle/cannula kitA collection of devices intended to be used to tighten loose or wrinkled skin and, optionally, cosmetically remove fat, through rotational force and suction provided by a dedicated console. It consists of a multiple coring needle array used to create a matrix of small circular holes in the skin which subsequently heal with contraction, a lipectomy cannula to be inserted subcutaneously into the fat layer for the aspiration of adipose tissue (fat), and a single coring needle for creating an opening in the skin for insertion of the lipectomy cannula. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+827052091112cwqc@mycw.co.kr

Regulatory Flags#

DUNS number
689894533
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809495930760Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-S142024-06-25
08809495930784Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-S492024-06-25
08809495930791Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-C142024-06-25
08809495930807Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-C252024-06-25
08809495930814Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-C492024-06-25
08809495931071FIXER DV9CWM-930S2024-06-25
08809495931088ELLISYS SENSECWM-930S2024-06-25
08809495931132FOOT SwitchCWM-930S-H132024-06-25
08809495931217Sterile Micro NeedleCWM-930S_ELLISYS TIP-12024-06-25
08809495931224Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-S362024-06-25
08809495931231Bi-polar Hand piece CableCWM-930S-H202024-06-25
08809495931248Bi-polar Hand pieceCWM-930S-Y012024-06-25
08809495931255Bi-polar Hand piece Suction FilterCWM-930S-Y022024-06-25
08809495931262Mono-polar Hand pieceCWM-930S-Y032024-06-25
08809495931279Neutral CableCWM-930S-H372024-06-25
08809495931286Neutral Pad9571C2024-06-25
08809495931309Hand Piece Electrode LIFTAE20-802024-08-30
08809495931316Hand Piece Electrode SMARTAE20-1802024-08-30
08809495931323Hand Piece Electrode LIPOAE40-3002024-08-30
08809495931330Electrode LIFT2X802024-08-30

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Primary DI, Brand, Company table
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