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Cellinew

by VIOL Co., Ltd.

510(k) K240897

Cellinew is a Class II device made by VIOL Co., Ltd., cleared under FDA 510(k) K240897 on 26 Nov 2024, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240897 Date26 Nov 2024ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEI
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K240897

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K240897
UDI-DISize and differences
CELLINEW
VIOL Co., Ltd.
CELLINEW08809502330347
Single use: no
On the market
CELLINEW Foot switch
VIOL Co., Ltd.
CELLINEW Foot Switch08809502330286
Single use: no
On the market
CELLINEW Handpiece
VIOL Co., Ltd.
CELLINEW Handpiece08809502330361
Single use: no
On the market
CELLINEW TIP CE25
VIOL Co., Ltd.
CE2508809502330385
Single use: yes
On the market
CELLINEW TIP CF40
VIOL Co., Ltd.
CF4008809502330378
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from VIOL Co., Ltd.

  • Scarlet Pro (Scarlet Pro)

    Class II

  • Cellinew

    Class II

  • Foot Switch F/S-Hrf-Blue

    Class II

  • Scarlet Srf

    Class II

See all devices from VIOL Co., Ltd. →