(169 days)
Not Found
No
The device description focuses on the physical components and laser parameters, with no mention of AI, ML, or image processing.
Yes
The device performs therapeutic actions such as Incision, excision, ablation, vaporization and hemostasis of soft tissue.
No
This device is a surgical laser system used for various soft tissue procedures (incision, excision, ablation, vaporization, hemostasis) and does not perform diagnostic functions.
No
The device description clearly outlines multiple hardware components including a laser optical rail assembly, articulated arm, power supply, cooling system, control electronics, and power distribution box. This indicates it is a physical medical device, 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 "Incision, excision, ablation, vaporization and hemostasis of soft tissue." This describes a surgical or therapeutic procedure performed directly on a patient's body.
- Device Description: The description details a laser system designed to interact with tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or alter tissue within the body. This device is clearly designed for direct interaction with soft tissue for therapeutic purposes.
N/A
Intended Use / Indications for Use
Incision, excision, ablation, vaporization and hemostasis of soft tissue
Product codes
Not Found
Device Description
Derma™ 20 is a pulsed medical laser system incorporating an Er:YAG laser, operating at a wavelength of 2.94 microns. The device emits pulses of up to 1.7 joules on tissue. The pulse width is 350 μsec, the pulse rate is 5-12 pulses per second. The system is composed of the following units: • Laser optical rail assembly • Articulated arm • Power supply and pulse forming network (PFN) • Cooling system • Control electronics system • Power distribution box
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
None
Description of the test set, sample size, data source, and annotation protocol
None
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): 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.
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
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
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510(K) PREMARKET NOTIFICATION
Derma™ 20 Laser System
ESC Medical Systems Ltd. Revised March 12,1997
510(K) Summary
| Submitter: | ESC Medical Systems Ltd.
Yokneam Industrial Park
Yokneam, 20692, Israel
Phone: 972-4-959-9000 Fax: 972-4-959-9050 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Zvi Ladin, VP, Clinical Applications and Regulatory Affairs |
| Date summary
prepared: | March 12, 1997 |
| Device Trade Name: | Derma™ 20 Laser System |
| Common name: | Erbium:YAG laser system |
| Classification name: | Laser instrument, powered, surgical (class II medical device) |
| Equivalent Devices: | SEO Trilase 2940 Erbium Laser (K954013)
Fotona Skinlight Laser System (K962902)
Continuum Biomedical Medlite/Erbium Laser System (K961748) |
| Device Description: | Derma™ 20 is a pulsed medical laser system incorporating an Er:YAG laser,
operating at a wavelength of 2.94 microns. The device emits pulses of up to 1.7
joules on tissue. The pulse width is 350 μsec, the pulse rate is 5-12 pulses per
second.
The system is composed of the following units:
• Laser optical rail assembly
• Articulated arm
• Power supply and pulse forming network (PFN)
• Cooling system
• Control electronics system
• Power distribution box |
| Intended Use: | Incision, excision, ablation, vaporization and hemostasis of soft tissue |
| Comparison: | The Trilase 2940 Erbium Laser, the Medlite\Erbium Laser System and the
Fotona Skinlight System are all Erbium:YAG lasers with pulse energy of up to 2
Joules and pulse rates 2-20 Hz. The Derma™ 20 Laser System characteristics
are within the range of these values. |
| Nonclinical
Performance Data | None |
| Clinical Performance
Data | None |
| Conclusion | The Derma™ 20 Laser System is substantially equivalent to other Erbium:YAG
laser systems in commercial distribution for similar surgical applications |
Additional Information None requested at this time