(90 days)
No
The summary describes a diode surgical laser system and its accessories for soft tissue procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The description focuses on the laser's physical capabilities and delivery systems.
Yes
The device is described as a "Surgical Laser" intended to incise, excise, vaporize, and coagulate soft tissue for various medical procedures, which are therapeutic actions.
No
This device is a surgical laser system intended for soft tissue incision, excision, vaporization, and coagulation, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "Diode Surgical Laser" and mentions "disposable fiber optic delivery systems," indicating it is a hardware device with physical components, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states the device is a "Diode Surgical Laser" intended for "soft tissue Incision, Excision, Vaporization and Coagulation" in various surgical procedures. This involves direct interaction with and modification of tissue within the body.
The device is a surgical tool used for treatment and modification of tissue, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The LIGHTFORCE 20/30 980mm Diode Surgical Laser is intended to provide the physician with a dependable laser system providing he/she the ability to incise, excise, vaporize and coagulate soft tissue in a variety of surgical procedures in various disciplines as listed:
Dermatology ENT/Head & Neck Gynecology
Gastroenterology General Surgery Neurosurgery
Pulmonary Urology Proctology
For soft tissue Incision, Excision, Vaporization and Coagulation:
- Gastroenterology
- General Surgery
- Gynecology
- ENT/Head & Neck
- Neurology
- Urology
- Pulmonary
- Plastic Surgery
Including:
- Gynecology-Endometrial Ablation (K871512)
- Urology Surgery (K871516)
- Rectal Patho. & Hemorrhoid (K871514)
- Gastro Intestinal Bleeding (K871515)
- Palliation of Gastro Malignancies (K871513)
- Pulmonary Obstructions (K871511A)
The LIGHTFORCE 20/30 980mm Diode Surgical Laser for soft tissue applications is accompanied by a variety of disposable fiber optic delivery systems for use in the different specialties. Each are compatible to all popular endoscopes on the market. A variety of Disposable Fiber Optic Delivery Systems are available for performing open and endoscopic surgical procedures with the LIGHTFORCE 20/30 980mm Diode Surgical Laser System for achieving incision, excision, vaporization and coagulation on soft tissue applications.
These disposable fiber optic delivery systems are available in various sizes (200, 400, 600, and 1000 micron) for performing contact and non-contact laser surgery techniques by the operating physician to assist in achieving Incision/Excision/Vaporization/Coagulation at CONTROLLABLE depths of tissue penetration from 0.3mm up to 4mm.
Product codes
GEX
Device Description
The LIGHTFORCE 20/30 980mm Diode Surgical Laser is intended to provide the physician with a dependable laser system providing he/she the ability to incise, excise, vaporize and coagulate soft tissue in a variety of surgical procedures in various disciplines.
The LIGHTFORCE 20/30 980mm Diode Surgical Laser for soft tissue applications is accompanied by a variety of disposable fiber optic delivery systems for use in the different specialties. Each are compatible to all popular endoscopes on the market. A variety of Disposable Fiber Optic Delivery Systems are available for performing open and endoscopic surgical procedures with the LIGHTFORCE 20/30 980mm Diode Surgical Laser System for achieving incision, excision, vaporization and coagulation on soft tissue applications. These disposable fiber optic delivery systems are available in various sizes (200, 400, 600, and 1000 micron) for performing contact and non-contact laser surgery techniques by the operating physician to assist in achieving Incision/Excision/Vaporization/Coagulation at CONTROLLABLE depths of tissue penetration from 0.3mm up to 4mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, Endometrial, Urological, Rectal, Gastrointestinal, Pulmonary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K871512, K871516, K871514, K871515, K871513, K871511A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
K04/419
AUG 2 6 2004
510 K General Summary
The LIGHTFORCE 20/30 980mm Diode Surgical Laser is intended to provide the physician with a dependable laser system providing he/she the ability to incise, excise, vaporize and coagulate soft tissue in a variety of surgical procedures in various disciplines as listed:
Dermatology ENT/Head & Neck Gynecology
Gastroenterology General Surgery Neurosurgery
Pulmonary Urology Proctology
The LIGHTFORCE 20/30 980mm Diode Surgical Laser for soft tissue applications is accompanied by a variety of disposable fiber optic delivery systems for use in the different specialties. Each are compatible to all popular endoscopes on the market. A variety of Disposable Fiber Optic Delivery Systems are available for performing open and endoscopic surgical procedures with the LIGHTFORCE 20/30 980mm Diode Surgical Laser System for achieving incision, excision, vaporization and coagulation on soft tissue applications.
These disposable fiber optic delivery systems are available in various sizes (200, 400, 600, and 1000 micron) for performing contact and non-contact laser surgery techniques by the operating physician to assist in achieving Incision/Excision/Vaporization/Coagulation at CONTROLLABLE depths of tissue penetration from 0.3mm up to 4mm.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2004
Mr. David P. Lewing Director of Regulatory Affairs Medical Energy, Inc. 225 E. Zaragoza Street Pensacola, Florida 32502
Re: K041419
Trade/Device Name: LIGHTFORCE 20/30 980nm Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 25, 2004 Received: May 28, 2004
Dear Mr. Lewing:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated 776 the enactment date of the Medical Device Amendments, or to conimeres prior to may 20, 1978) ... . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ................................................................... and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and coometer for ( 10) read the device, subject to the general controls provisions of the Act. The r ou may, dierefore, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or sations in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Crth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty byrovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. David P. Lewing
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and my of your finding of substantial equivalence of your device to a legally promative noticated in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Mellman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(K) Number: K041419
LIGHTFORCE 20/30 980nm Diode Laser Device Name:
Indications For Use:
- For soft tissue Incision, Excision, Vaporization and Coagulation: 1.
-
- Gastroenterology
-
- General Surgery
-
- Gynecology
-
- ENT/Head & Neck
-
-
- Neurology
-
- Urology
-
- Pulmonary
-
- Plastic Surgery
Including:
-
- Gynecology-Endometrial Ablation (K871512)
-
- Urology Surgery (K871516)
-
- Rectal Patho. & Hemorrhoid (K871514)
-
- Gastro Intestinal Bleeding (K871515)
-
- Palliation of Gastro Malignancies (K871513)
-
- Pulmonary Obstructions (K871511A)
| Prescription Use _____________________________________________________________________________________________________________________________________________________________ | AND/OR | Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number K041419