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Joule diVa System

by Sciton, Inc

510(k) K213761

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.

Overview

Palo Alto-based medical device manufacturer Sciton, Inc. has announced that its Joule diVa System has been deemed Substantially Equivalent to an FDA-cleared medical device. As such, the company is now authorized to market and sell its products in all 50 states, including California.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213761 Date19 Jul 2022ClearedStatusActive

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  • Withdrawn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
GEX
Device class
Class II
Regulation
21 CFR Part 878.4810
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 K213761

1 device · 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 K213761
UDI-DISize and differences
Joule Diva System
SCITON, INC.
1500-XXX-XX / Joule Diva System00863249000350 —On the market

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Sciton, Inc.

  • Joule Diva System

    Class II

  • BBLs

    Class II

  • mJoule

    Class II

  • Joule

    Class II

See all devices from Sciton, Inc. →