(183 days)
Not Found
No
The summary describes a laser device for treating pigmented lesions and tattoo removal, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is intended for the "Treatment of pigmented lesions," which indicates a therapeutic purpose.
No
This device is described as a laser for the "Treatment of pigmented lesions" and "for tattoo removal," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a "flashlamp excited Q-switched solid state laser," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Treatment of pigmented lesions." This describes a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser used for treatment. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, providing diagnostic information, or being used in a laboratory setting.
Therefore, the Medlite\755 Alexandrite Laser is a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Treatment of pigmented lesions.
Product codes
GEX
Device Description
The Medlite\755 Alexandrite Laser is a flashlamp excited Q-switched solid state laser producing a broadband wavelength of 755 ±25nm. Medlite\755™ Alexandrite Laser System is currently marketed under K935631, SE date 08/23/94, for tattoo removal.
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)
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
,
SEP 11 1996 K96/006
:
510(k) Summary
| Submitter: | Continuum Biomedical, Inc.
547 Rhea Way
Livermore, CA 94550
Phone: 510-606-3750
Fax: 510-371-1015 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Robert S. Anderson, Ph. D.
President |
| Date Summary Prepared: | March 11, 1996 |
| Device Trade Name: | Medlite\755TM Alexandrite Laser System |
| Common Name: | Dermatology laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | PhotoGenicaT10 Laser (Cynosure) K950684 |
| Device Description: | The Medlite\755 Alexandrite Laser is a flashlamp excited Q-switched
solid state laser producing a broadband wavelength of 755 ±25nm.
Medlite\755™ Alexandrite Laser System is currently marketed under
K935631, SE date 08/23/94, for tattoo removal. |
| Intended Use: | Treatment of pigmented lesions. |
| Comparison: | Cynosure's PhotoGenica T10 Laser emits light at 752nm in a flashlamp-
excited pulsed mode. Indications for use, target, chromophore, delivery
system, spot size, mode of operation, exposure duration, average laser
power, energy to lesion aiming beam, laser wavelength, etc. for the
Medlite\755 Alexandrite Laser System are all within the parameters
currently in use by other systems which have been previously found to
be substantially equivalent. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Medlite\755 Alexandrite Laser System is substantially equivalent to
other existing surgical laser systems in commercial distribution for the
treatment of pigmented lesions. |
| Additional Information: | None requested at this time. |