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Wav30

by CLASSYS Inc.

Wav30 is a device made by CLASSYS Inc., cleared under FDA 510(k) K241157 on 21 Nov 2024 and listed in FDA GUDID since 2 Jul 2025 (UDI-DI 08800016905090), 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) K241157

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 Number08800016905090 UDI-DI Date2 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241157 Date21 Nov 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241157 decided 21 Nov 2024 Active
  • FDA GUDID UDI-DI 08800016905090 listed 2 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241157
  2. Listed FDA GUDID 08800016905090

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Radio-frequency skin contouring system applicator tip
Model / reference
WAV30
Primary DI / UDI-DI
08800016905090
510(k) Number
GMDN term
Radio-frequency skin contouring system applicator tip
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Radio-frequency skin contouring system applicator tip.

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)