(76 days)
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No
The provided text describes a diode laser system for soft tissue surgery and does not mention any AI or ML capabilities.
Yes
The device is indicated for various surgical procedures, including photocoagulation, photothermolysis, and removal of lesions, which are therapeutic interventions.
No
Justification: The device's intended use is for surgical procedures involving incision/excision, ablation, and coagulation of soft tissue, indicating a therapeutic rather than diagnostic function.
No
The device description clearly identifies it as a "Diode Laser System and Accessories," which are hardware components, not software.
Based on the provided information, the Uni-laser 425P Diode Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc., to provide information about a person's health.
- The Uni-laser 425P is a surgical laser system. Its intended use is for direct surgical procedures on soft tissue within the body (incision, excision, ablation, coagulation). It is not used to analyze samples outside of the body.
The description clearly outlines its use in various surgical specialties for treating tissues directly, which is the function of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Uni-laser 425P Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:
Dermatology and Plastic Surgery for
Photocoagulation of dermatological vascular lesions Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions
Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only); Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery;
Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands; periodontal pocket; facial and leg veins
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1999
Marilyn M. Chou, Ph.D. Regulatory Consultant MedArt Corporation 11772 Sorrento Valley Road Suite 240 San Diego, California 92121
Re: K991659
Trade Name: Uni-Laser 425P™ Diode Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: May 13, 1999 Received: May 14, 1999
Dear Dr. Chou:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Marilyn M. Chou, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number : K 991659
Uni-laser 425P™ Diode Laser System Device Name:
Indications For Use:
The Uni-laser 425P Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:
Dermatology and Plastic Surgery for
Photocoagulation of dermatological vascular lesions Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions
Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only); Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery;
Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of General Restorative Devices K 991659
510(k) Number
Prescription Use _ (21 CFR 801.109)
OR
Over-The-Counter Use