(259 days)
No
The summary describes a laser system accessory with optical components and does not mention any AI/ML terms or functionalities.
Yes
The device is described for "the removal of tattoos and the treatment of vascular and pigmented lesions," which are therapeutic applications.
No
The "Intended Use / Indications for Use" section states the device is "for the removal of tattoos and the treatment of vascular and pigmented lesions," which are therapeutic actions, not diagnostic. There is no mention of identifying, analyzing, or predicting a medical condition or disease.
No
The device description explicitly states it consists of hardware components like a handpiece, dye module, power meter, and safety goggles, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of tattoos and the treatment of vascular and pigmented lesions in dermatology. This is a therapeutic and cosmetic application, not a diagnostic one.
- Device Description: The description details a laser system accessory used for delivering laser energy to tissue. This is consistent with a therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
For use in dermatology for the removal of tattoos and the treatment of vascular and pigmented lesions.
Product codes
79-GEX
Device Description
The new Dye Accessory Handpiece for the Medlite™ Nd:YAG Laser System is consists of four primary parts: the handpiece which contains a short optical cavity and focusing optics, the plastic dye module, the commercial power meter and appropriate laser safety goggles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics
Not Found
Predicate Device(s)
Medlite™ Nd:YAG Laser System (K955131, K952636, K940607, K940636, K922935, K922577, K915497)
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
K 963340
| Submitter: | Continuum Biomedical, Inc.
2456 Armstrong Street
Livermore, CA 94550-7617
Phone: 510-606-3750
Fax: 510-371-1015 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Robert S. Anderson, Ph. D.
President |
| Date Summary Prepared: | August 23, 1996 |
| Device Trade Name: | Medlite™ Nd:YAG Laser System: New Dye Accessory Handpiece |
| Common Name: | Dermatology laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Medlite™ Nd:YAG Laser System (K955131, K952636, K940607,
K940636, K922935, K922577, K915497) |
| Device Description: | The new Dye Accessory Handpiece for the Medlite™ Nd:YAG Laser
System is consists of four primary parts: the handpiece which contains
a short optical cavity and focusing optics, the plastic dye module, the
commercial power meter and appropriate laser safety goggles. |
| Intended Use: | For use in dermatology for the removal of tattoos and the treatment of
vascular and pigmented lesions. |
| Comparison: | The new Dye Accessory Handpiece allows the Medlite™ Nd: YAG Laser
System to deliver slightly altered wavelengths for increased efficiency in
treating tattoos, vascular and pigmented lesions. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Medlite™ Nd:YAG Laser System is substantially equivalent to other
existing surgical laser systems in commercial distribution for the
treatment of tattoos, vascular and pigmented lesions. |
| Additional Information: | None requested at this time. |
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