Description
This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.
Scope & Applicability
Product Classes
6The primary subject of the guidance document; Subject of the premarket notification guidance; Guidance on the Content and Organization of a Premarket Notification for a Medical Laser
consisting of a laser console, a power supply, and a fiber-optic delivery system
Subject to premarket approval due to new intended use
General manual surgical instruments exempt from 510(k)
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Class III subject to the 510(k) or PMA requirements
Stakeholders
6Governs top dose in clinical studies
FDA may seek advice when considering the initiation or progress of a PAS
Entity submitting development data and knowledge; Entity performing the work process for change
Provides clinical judgment and conducts assessments for ClinROs.
Entity responsible for submitting NDINs
Institutional Review Board providing study approvals
Regulatory Context
Attributes
3Standard for 510(k) clearance
Determination of the absence of fever-producing substances
Classification of metallic and calcium phosphate coated orthopedic devices
Identified Hazards
Hazards
5critical nerves or vessels that could be irreversibly damaged by thermal or acoustic effects
Risks to tissues or organs which may be adversely affected if struck by stray or scattered laser radiation
Warnings regarding gas emboli particularly where documented or highly likely
unavoidable risks of fire or explosion if a laser were to be used
critical nerves or vessels that could be irreversibly damaged
Related CFR Sections (10)
- 21CFR874.4490§ 874.4490 Argon laser for otology, rhinology, and laryngology.
(a) Identification. The argon laser device for use in otology, rhinology, and laryngology is an electro-optical device which produces coherent, electromagnetic radiation with principal wavelength peaks of 488 and 514 nanometers. In otology, the device is used for the purpose of coagulating and vaporRead full regulation →
- 21CFR874.4500§ 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.
(a) Identification. An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areaRead full regulation →
- 21CFR878.4810§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a) Identification.Read full regulation →
- 21CFR884.4550§ 884.4550 Gynecologic surgical laser.
(a) Identification. A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifyiRead full regulation →
- 21CFR886.4390§ 886.4390 Ophthalmic laser.
(a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.Read full regulation →
- 21CFR886.4392§ 886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
(a) Identification. The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a mode-locked or Q-switched solid state Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser generates short pulse, low energy, high power,Read full regulation →
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 21CFR1040.10§ 1040.10 Laser products.
(a) Applicability. The provisions of this section and § 1040.11 , as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when:Read full regulation →
- 21CFR1040.11§ 1040.11 Specific purpose laser products.
(a) Medical laser products. Each medical laser product shall comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, the manufacturer shall:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
- 2024-03-12
Investigational Review Board (IRB)
Nobles Medical Technology II, Inc.
See Also (8)
- Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)
- Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards (Status: Draft)
- Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry (Status: Draft)