(81 days)
No
The summary describes a laser device with standard components and parameters, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is described for use in dermatology for various procedures like incision, excision, ablation, vaporization, and hemostasis of soft tissue, which are all therapeutic actions.
No
Explanation: The device description states its use for "incision, excision, ablation, vaporization and hemostasis of soft tissue" in dermatology, which are all treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a laser system consisting of hardware components (power supply, water cooling system, optical bench).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures on soft tissue (incision, excision, ablation, vaporization, and hemostasis) in dermatology. This is a therapeutic and surgical application, not a diagnostic one performed in vitro (outside the body).
- Device Description: The device is a laser system designed to interact directly with tissue. IVD devices typically analyze samples (blood, urine, tissue, etc.) in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical laser, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.
Product codes
79-GEX
Device Description
The Medlite\Erbium Laser is an erbium laser producing laser emissions at 2.94micrometers . The laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 10 watts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 (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)
SEO Medical TriLase 2940 Erbium Laser System (K954013)
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
JUL 26 1996
510(k) Summary
| 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: | July 12, 1996 |
| Device Trade Name: | Medlite\Erbium Laser System |
| Common Name: | Dermatology laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | SEO Medical TriLase 2940 Erbium Laser System (K954013) |
| Device Description: | The Medlite\Erbium Laser is an erbium laser producing laser emissions
at 2.94 $\mu$ . The laser consists of three interconnected sections: the power
supply, the water cooling system and the optical bench. At 5 pulses per
second and a pulse energy of 2 Joules, the average power from the
laser is 10 watts. |
| Intended Use: | For use in dermatology for the incision, excision, ablation, vaporization
and hemostasis of soft tissue. |
| Comparison: | The TriLase 2940 Erbium Laser has the ability to deliver laser energy at
2.94 microns, maximum power of 5 watts at repetition rates of up to 20
pulses per second. These characteristics are very similar to the
Medlite\Erbium Laser System. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Medlite\Erbium Laser System is substantially equivalent to other
existing surgical laser systems in commercial distribution for
dermatology treatments such as skin resurfacing and dermabrasion. |
| Additional Information: | None requested at this time. |
.