(22 days)
Not Found
No
The document describes a laser device with standard components and mentions computer software for control, but there is no indication of AI or ML being used for analysis, decision-making, or treatment planning.
Yes.
The device is used for medical treatments such as "coagulation, vaporization, ablation or cutting of soft tissue" and "skin resurfacing, treatment of wrinkles, and superficial skin lesions" in various medical specialties.
No
The device is described as a laser system for tissue coagulation, vaporization, ablation, or cutting, and its indicated uses are for treatment purposes such as skin resurfacing and wrinkle treatment, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a console, handpiece, footswitch, and trolley/cart. While it mentions being controlled by computer software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the LaserPeel Soft-MET Modified Erbium Laser is used for coagulation, vaporization, ablation, or cutting of soft tissue directly on the patient's body. It is a surgical/therapeutic device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use describes procedures performed on the patient's skin and other soft tissues for treatment purposes (skin resurfacing, wrinkle treatment, lesion treatment).
- Device Description: The components and operation described are consistent with a laser used for surgical or aesthetic procedures, not for analyzing biological samples.
Therefore, the LaserPeel Soft-MET Modified Erbium Laser falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indicated at 2940 nm for Fitzpatrick skin types I-V for coagulation, vaporization, ablation or cutting of soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology. Specifically indicated for skin resurfacing, treatment of wrinkles, and superficial skin lesions.
Product codes
GEX
Device Description
The LaserPeel Soft-MET Modified Erbium Laser is a compact self-contained device that delivers a beam of laser energy at an infrared wavelength of 2940 nm to the treatment site. The LaserPeel Soft-MET Modified Erbium Laser consists of four primary components:
- A console which houses the power supply, electronics, cooling system, and liquid crystal display screen (LCD);
- A handpiece which contains the laser cavity and optical delivery system and is connected to the console by an umbilical cord:
- An on/off footswitch; and
- An integrated trolley/cart.
The LaserPeel Soft-MET Modified Erbium Laser is not battery operated, but is controlled and operated with the aid of computer software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology
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)
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary
Global USA Distribution, LLC LaserPeel Soft-MET Modified Erbium Laser 510(k) Premarket Notification
AUG - 8 2008
| Submitter: | Global USA Distribution, LLC |
|---|---|
| Address: | 10723 Aquila Av. S. |
| Minneapolis, MN 55438 | |
| Contact Person: | Matt Makousky |
| Telephone: | 952-703-5373 |
| Facsimile: | 952-888-8887 |
| Date Prepared: | April 1, 2008 |
| Device Trade Name: | LaserPeel Soft-MET Modified Erbium Laser |
| Classification Name: | Instrument, Powered, Laser |
| 79-GEX 21 CFR 878.4810 | |
| Legally Marketed Predicate Devices: | Medical Laser Technologies MLT ErbiumYAG |
| Laser System (K032599), | |
| Alma Lasers Ltd. (formerly MSq (M2) Ltd) | |
| (K042000) |
Description of the LaserPeel Soft-MET Modified Erbium Laser:
The LaserPeel Soft-MET Modified Erbium Laser is a compact self-contained device that delivers a beam of laser energy at an infrared wavelength of 2940 nm to the treatment site. The LaserPeel Soft-MET Modified Erbium Laser consists of four primary components:
- A console which houses the power supply, electronics, cooling system, and liquid crystal display screen (LCD);
1
-
A handpiece which contains the laser cavity and optical delivery system and is connected to the console by an umbilical cord:
-
An on/off footswitch; and
-
An integrated trolley/cart.
The LaserPeel Soft-MET Modified Erbium Laser is not battery operated, but is controlled and operated with the aid of computer software.
Intended Use of the LaserPeel Soft-MET Modified Erbium Laser:
Indicated at 2940 nm for Fitzpatrick skin types I-V for coagulation, vaporization, ablation or cutting of soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology. Specifically indicated for skin resurfacing, treatment of wrinkles, and superficial skin lesions.
| Nonclinical Performance
| Data: | None |
|---|---|
| Clinical Performance | |
| Data: | None |
| Additional Information | None requested at this time |
| Conclusion: | The LaserPeel Soft-MET Modified Erbium Laser is |
| substantially equivalent to other existing legally | |
| marketed laser systems currently in commercial | |
| distribution. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Global USA Distribution, LLC % Underwriters Laboratories, Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062-2096
AUG - 8 2008
Re: K082028
Trade/Device Name: LaserPeel Soft-MET Modified Erbium 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: July 31, 2008 Received: August 1, 2008
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 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 comply 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
3
Page 2 – Mr. Ned Devine
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark H. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K082028
Device Name: LaserPeel Soft-MET Modified Erbium Laser
Indications for Use:
Indicated at 2940 nm for Fitzpatrick skin types I-V for coagulation, vaporization, ablation or cutting of soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology. Specifically indicated for skin resurfacing, treatment of wrinkles, and superficial skin lesions.
Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off) (Division Division of General, Restorative, and Neurological 510(%) Number
Page 1 of 1