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Diode Laser Tips Pre-Initiated, Perio, 3-9

by Biolase, Inc.

Diode Laser Tips Pre-Initiated, Perio, 3-9 (7400065) is a Class II device made by Biolase, Inc., cleared under FDA 510(k) K121286 on 28 Sep 2012 and listed in FDA GUDID since 30 Nov 2016 (UDI-DI 00647529003305), 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) K121286

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 Number00647529003305 UDI-DI Date30 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK121286 Date28 Sep 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121286 decided 28 Sep 2012 Active
  • FDA GUDID UDI-DI 00647529003305 listed 30 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121286
  2. Listed FDA GUDID 00647529003305

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  • Withdrawn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 / Ref / Catalog
Pre-Initiated, Perio, 3-9, 7400065
Primary DI / UDI-DI
00647529003305
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 — 9 Millimeter
Outer Diameter — 300 Micrometer

Related devices

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

Cleared under the same submission (K121286)

and 8 more cleared under K121286

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)