Skip to content

Silkro

by Hironic Co., Ltd. 2 variants

510(k) K233123

Silkro is a Class II device made by Hironic Co., Ltd., cleared under FDA 510(k) K233123 on 24 Jun 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 NumberK233123 Date24 Jun 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  • Withdrawn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

Cited by

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

Devices cleared under K233123

16 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 K233123
UDI-DISize and differences
A-FIT RF Needle Tip A-FIT RN 1.2
Hironic Co., Ltd.
A-FIT RN 1.208800016273014
Prescription: yes; Single use: yes
On the market
A-FIT RF Needle Tip A-FIT RN 1.5
Hironic Co., Ltd.
A-FIT RN 1.508800016273021
Prescription: yes; Single use: yes
On the market
A-FIT RF Needle Tip A-FIT RN 1.8
Hironic Co., Ltd.
A-FIT RN 1.808800016273038
Prescription: yes; Single use: yes
On the market
GP Cable
Hironic Co., Ltd.
GP Cable08800016273151
Prescription: no; Single use: no
On the market
PS Handpiece
Hironic Co., Ltd.
PS Handpiece08800016273106
Prescription: yes; Single use: no
On the market
PS Tip
Hironic Co., Ltd.
PS Tip08800016273250
Prescription: yes; Single use: no
On the market
RC Handpiece
Hironic Co., Ltd.
RC Handpiece08800016273137
Prescription: yes; Single use: no
On the market
RF Micro Needle Tip RMT-I25
Hironic Co., Ltd.
RMT-I2508800016273052
Prescription: yes; Single use: yes
On the market
RF Micro Needle Tip RMT-I49
Hironic Co., Ltd.
RMT-I4908800016273076
Prescription: yes; Single use: yes
On the market
RF Micro Needle Tip RMT-N25
Hironic Co., Ltd.
RMT-N2508800016273045
Prescription: yes; Single use: yes
On the market
RF Micro Needle Tip RMT-N49
Hironic Co., Ltd.
RMT-N4908800016273069
Prescription: yes; Single use: yes
On the market
RF Venus Stick
Hironic Co., Ltd.
RF Venus Stick08800016273182
Prescription: yes; Single use: no
On the market
RM Handpiece
Hironic Co., Ltd.
RM Handpiece08800016273083
Prescription: yes; Single use: no
On the market
RN Handpiece
Hironic Co., Ltd.
RN Handpiece08800016273120
Prescription: yes; Single use: no
On the market
RV Handpiece
Hironic Co., Ltd.
RV Handpiece08800016273144
Prescription: yes; Single use: no
On the market
SILKRO
Hironic Co., Ltd.
SILKRO08800016213027
Prescription: yes; Single use: no
On the market

Similar devices

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

Other devices from Hironic Co., Ltd.

See all devices from Hironic Co., Ltd. →