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miraDry MD4500-BT

by miraDry Inc.

miraDry MD4500-BT is an electrosurgical system generator (FDA Class II) made by miraDry Inc., cleared under FDA 510(k) K180396 on 15 Mar 2018 and listed in FDA GUDID since 13 Sep 2018 (UDI-DI 00853419006039), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K180396

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00853419006039 UDI-DI Date13 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK180396 Date15 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180396 decided 15 Mar 2018 Active
  • FDA GUDID UDI-DI 00853419006039 listed 13 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180396
  2. Listed FDA GUDID 00853419006039

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
miraDry
Generic name
Electrosurgical system generator
Model / Ref / Catalog
MD4500-BT
Primary DI / UDI-DI
00853419006039
510(k) Number
FDA product code
MWY, NEY, OUB
GMDN term
Electrosurgical system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrosurgical system generator

Similar devices in this category

Other devices filed under Electrosurgical system generator.

Other devices from miraDry Inc.

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (10, all answered No)