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Smart kit Basic SKT-061

by Bsl Co.

Smart kit Basic SKT-061 is a Class II device made by Bsl Co., listed under FDA premarket submission BK220722 and listed in FDA GUDID since 11 May 2023 (UDI-DI 08800080200060), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) BK220722

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800080200060 UDI-DI Date11 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK220722 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK220722 Active
  • FDA GUDID UDI-DI 08800080200060 listed 11 May 2023 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Smart kit Basic
Generic name
Autologous adipose tissue reinjection set
Model / reference
SKT-061
Primary DI / UDI-DI
08800080200060
FDA product code
QKL
GMDN term
Autologous adipose tissue reinjection set
Device class
Class II
Regulation number
878.5040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Autologous adipose tissue reinjection set

Cleared under the same submission (BK220722)

and 8 more cleared under BK220722

Similar devices

Other devices filed under FDA product code QKL (Lipoaspirate Washing System For Aesthetic Body Contouring).

Other devices from Bsl Co.

See all devices from Bsl Co. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)