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Diode Laser Tips E4-60 EZTip

by Biolase, Inc.

Diode Laser Tips E4-60 EZTip is a Class II device made by Biolase, Inc., cleared under FDA 510(k) K130465 on 11 Apr 2013 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00647529000397), active as of 22 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 22 Oct 2026

Documents

510(k) K130465

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00647529000397 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130465 Date11 Apr 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130465 decided 11 Apr 2013 Active
  • FDA GUDID UDI-DI 00647529000397 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130465
  2. Listed FDA GUDID 00647529000397

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diode Laser Tips
Generic name
General/multiple surgical laser system beam guide, single-use, non-sterile
Model / reference
E4-60 EZTip
Primary DI / UDI-DI
00647529000397
510(k) Number
FDA product code
GEX
GMDN term
General/multiple surgical laser system beam guide, single-use, non-sterile
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 60 Millimeter
Outer Diameter — 400 Micrometer

Related devices

Category: General/multiple surgical laser system beam guide, single-use, non-sterile

Cleared under the same submission (K130465)

Similar devices

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

Other devices from Biolase, Inc.

See all devices from Biolase, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)