Product Code: LLO FDA class 2 21 CFR 874.4500

Laser, Neodymium:Yag, Pulmonary Surgery

Ear, Nose, Throat

Laser, Neodymium:YAG, Pulmonary Surgery is a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser system used in surgical procedures involving the lungs and airways, such as bronchoscopic resection of endobronchial tumors or treatment of tracheobronchial obstructions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLO, regulated under 21 CFR 874.4500, within the Ear, Nose, and Throat medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: LLO
Device Class: FDA class 2
Regulation Number: 874.4500
Medical Specialty: Ear, Nose, Throat
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K884815	SLT CLMD CONTACT LASER	Dec 22, 1988	Substantially Equivalent	Surgical Laser Technologies, Inc.
K881499	SURGILASE YAG 100 FOR GYNECOLOGY USE	Apr 29, 1988	Substantially Equivalent	Surgilase, Inc.
K880592	LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE	Apr 25, 1988	Substantially Equivalent	Laser Peripherals, LLC
K880170	MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS	Mar 24, 1988	Substantially Equivalent	Cooper Lasersonics, Inc.
K874254	ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS	Mar 04, 1988	Substantially Equivalent	Minnesota Laser Corp.
K875104	SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE	Feb 02, 1988	Substantially Equivalent	Laserguide
K871876	MODEL 5050 SURGILASER FOR PULMONARY USE	Jan 22, 1988	Substantially Equivalent	Lasermatic, Inc.
K872351	FIBERLASE II ND:YAG LASER FOR PULMONARY USE	Dec 11, 1987	Substantially Equivalent	Laser Media
K870505	OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL	Aug 07, 1987	Substantially Equivalent	Trimedyne, Inc.
K871511	SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS	Jul 21, 1987	Substantially Equivalent	Medical Energy, Inc.
K862698	6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION	Aug 05, 1986	Substantially Equivalent	Cooper Lasersonics, Inc.
K861921	LASER BRONCHOSCOPE SYSTEM	Jun 02, 1986	Substantially Equivalent	Pilling Co.
K861583	CO2 LASER BRONCHOSCOPE SYSTEM	May 21, 1986	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K861045	MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT	Apr 23, 1986	Substantially Equivalent	Sharplan Industries, Inc.
K855095	S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA	Feb 18, 1986	Substantially Equivalent	Surgical Laser Technologies, Inc.
K852761	CILAS MODEL YM101	Nov 14, 1985	Substantially Equivalent	Inframed, Inc.
K852507	ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION	Jul 05, 1985	Substantially Equivalent	Endo Lase, Inc.
K850432	LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS-	Feb 15, 1985	Substantially Equivalent	Cooper Lasersonics, Inc.
K844869	FIBERLASE 100 MEDICAL LASER SYSTEM	Jan 14, 1985	Substantially Equivalent	Laser Media