Epic S-Series Diode Laser System

FDA UDI

Class II (US FDA UDI)

by Biolase, Inc.

Identity

Trade Name: Epic S-Series Diode Laser System FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
Model / Reference: 7400054 FDA UDI
Description: A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI

Identifiers

Catalog Number: 7400054 FDA UDI
Primary DI / UDI-DI: 00647529000236 FDA UDI
510(k) Number: K130465 FDA UDI
FDA Product Code: GEX FDA UDI
ILY FDA UDI
GMDN Term: General/multiple surgical diode laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
890.5500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: General/multiple surgical diode laser system

Epic S-Series Diode Laser System by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical diode laser system.

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TxCell for IQ577, H/S 900BM/BQ & CSO9900 — Iridex Corporation · Class II
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Assy Final HS SLA IQ532 Standard Mount — Iridex Corporation · Class II
Visualase — MEDTRONIC NAVIGATION, INC. · Class I
GIGAA — Wuhan Gigaa Optronics Technology Co., Ltd. · Class II
Ultrafast Diode Laser — DENTLIGHT INC. · Class II

Cleared under the same submission

K130465 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biolase, Inc.

Sources (1)

FDA UDI fc183733-e116-4592-9b22-42217a75313f 36 fields · synced May 30, 2026