← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K964253

# DERMA  20 LASER SYSTEM (K964253)

_Esc Medical Systems , Ltd. · GEX · Apr 11, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964253

## Device Facts

- **Applicant:** Esc Medical Systems , Ltd.
- **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md)
- **Decision Date:** Apr 11, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Intended Use

Incision, excision, ablation, vaporization and hemostasis of soft tissue

## Device Story

Derma™ 20 is a pulsed Erbium:YAG laser system; operates at 2.94 micron wavelength; delivers pulses up to 1.7 joules; pulse width 350 μsec; pulse rate 5-12 Hz. System components: laser optical rail, articulated arm, power supply/pulse forming network, cooling system, control electronics, power distribution box. Used by physicians in clinical/surgical settings for soft tissue procedures. Laser energy ablates/vaporizes tissue; provides hemostasis. Output controlled via electronics; enables precise surgical tissue management.

## Clinical Evidence

No clinical data provided. No nonclinical performance data provided.

## Technological Characteristics

Erbium:YAG laser; 2.94 micron wavelength; 1.7J max pulse energy; 350 μsec pulse width; 5-12 Hz pulse rate. System includes articulated arm delivery, cooling system, and electronic control unit.

## Regulatory 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.

## Predicate Devices

- SEO Trilase 2940 Erbium Laser ([K954013](/device/K954013.md))
- Fotona Skinlight Laser System ([K962902](/device/K962902.md))
- Continuum Biomedical Medlite/Erbium Laser System ([K961748](/device/K961748.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

APR 11 1997
K964253

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

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964253](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964253)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com