Skip to content

Scarlet Srf

by VIOL Co., Ltd.

510(k) K180872

Scarlet Srf is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by VIOL Co., Ltd., cleared under FDA 510(k) K180872 on 11 Oct 2018, 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 NumberK180872 Date11 Oct 2018ClearedStatusActive

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  • Withdrawn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 K180872

4 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 K180872
UDI-DISize and differences
FOOT SWITCH F/S-HRF-BLUE
VIOL Co., Ltd.
F/S-HRF-BLUE08809502330439
Prescription: no
On the market
HAND PIECE H/S_03
VIOL Co., Ltd.
H/S_0308809502330446
Prescription: no
On the market
SCARLET PRO
VIOL Co., Ltd.
SCARLET PRO08809502330422
Prescription: yes
On the market
SCARLET SRF
VIOL Co., Ltd.
SCARLET SRF08809502330088
Prescription: no
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. →