(88 days)
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No
The provided text describes a CO2 laser system for surgical applications and lists various medical specialties and procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description or intended use.
Yes
The device is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in various medical specialties for the treatment of a wide range of medical conditions, which falls under the definition of a therapeutic device.
No
The device is indicated for surgical applications involving the modification of soft tissue (ablation, vaporization, excision, incision, coagulation), not for diagnosing conditions.
No
The device is described as a "CO2 Laser System & Accessories," which inherently involves hardware components for generating and delivering laser energy. The intended uses also describe surgical procedures requiring physical interaction with tissue, which is performed by the laser hardware.
Based on the provided information, the Uni-laser 450P CO2 Laser System & Accessories is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in vivo (within a living organism).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
The Uni-laser 450P directly interacts with and modifies tissue within the patient's body, which is the opposite of an IVD.
N/A
Intended Use / Indications for Use
The Uni-laser 450P CO2 Laser System & Accessories are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open and endoscopic general surgery.
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
Laser skin resurfacing
Treatment of wrinkles, rhytids and furrows
Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas) tattoos, telangiectasia, squarnous and basal cell carcinoma, spider and epidermal nacvi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surgery & General Surgery
Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Soft Tissue Dental
The specific soft tissue dental indications include: Periodontic procedures such as gingivectomy-removal of hyperplasias, gingivoplasty, and incision and excision:
Oral Surgery such as frenectomy, incisional and excisional biopsy, incision and excision of aphous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, homeostasis, operculectorny, and crown lengthening.
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.
Otorhinolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia g larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillornatosis politic rhinophyma and verrucae vulgares.
Gynecology
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.
Neurosurgery
Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large turnors.
Product codes (comma separated list FDA assigned to the subject device)
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 in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open and endoscopic general surgery, skin, gingiva, oral cavity, ear, nose, throat, cervix, vulva, vagina, brain, peripheral nerves, lipoma, tumors
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 features a stylized eagle with three horizontal lines above it, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1.2 1999
Marilyn M. Chow, Ph.D. Regulatory Consultant MedArt Corporation 11772 Sorrento Valley Road Suite 240 San Diego, California 92121
Re: K991297
Trade Name: Uni-Laser 450P CO2 Laser System & Accesories Regulatory Class: II Product Code: GEX Dated: June 23, 1999 Received: June 24, 1999
Dear Dr. Chow:
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.
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
1
Page 2 - Marilyn Chow,Ph.D.
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) 594-4659. 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
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| 510(k) Number : | #K991297 |
|---|---|
| ----------------- | ---------- |
Uni-laser 450P CO2 Laser System & Accessories Device Name:
Indications For Use:
The Uni-laser 450P CO2 Laser System & Accessories are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open and endoscopic general surgery.
Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
Laser skin resurfacing
Treatment of wrinkles, rhytids and furrows
Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas) tattoos, telangiectasia, squarnous and basal cell carcinoma, spider and epidermal nacvi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surgery & General Surgery Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Soft Tissue Dental The specific soft tissue dental indications include: Periodontic procedures such as gingivectomy-removal of hyperplasias, gingivoplasty, and incision and excision:
Oral Surgery such as frenectomy, incisional and excisional biopsy, incision and excision of aphous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, homeostasis, operculectorny, and crown lengthening.
Podiatry Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.
Otorhinolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia g larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillornatosis politic rhinophyma and verrucae vulgares.
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
(Division Sigh-Off)
Division of General Restorative Devices 99129
510(k) Number
3
Page 2 of 2
Gynecology Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.
Neurosurgery Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large turnors.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (21 CFR 801.109
Over-The-Counter Use _
Dioceles
Sign-Off
of General Restorative Devices
510(k) Number K991297