Who is the manufacturer of DERMA 20 LASER SYSTEM?

Esc Medical Systems , Ltd. filed the 510(k) submission for DERMA 20 LASER SYSTEM (K964253).

What is the FDA product code for DERMA 20 LASER SYSTEM?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DERMA 20 LASER SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DERMA 20 LASER SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DERMA 20 LASER SYSTEM

Q: What are the predicate devices for DERMA 20 LASER SYSTEM?

SEO Trilase 2940 Erbium Laser (K954013); Fotona Skinlight Laser System (K962902); Continuum Biomedical Medlite/Erbium Laser System (K961748).

K964253 · Esc Medical Systems , Ltd. · GEX · Apr 11, 1997 · General, Plastic Surgery

Device Facts

Record ID	K964253
Device Name	DERMA 20 LASER SYSTEM
Applicant	Esc Medical Systems , Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Apr 11, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
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.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and hemostasis of soft tissue in patients requiring surgical intervention.

Regulatory Classification

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)
Fotona Skinlight Laser System (K962902)
Continuum Biomedical Medlite/Erbium Laser System (K961748)

Related Devices

K961748 — MEDLITE/ERBIUM LASER SYSTEM · Continuum Biomedical, Inc. · Jul 26, 1996
K991632 — FOTONA NOVALIS ER: YAG LASER SYSTEM · Fotona D.D. · Aug 10, 1999
K014057 — DERMASTAR ER:YAG LASER SYSTEM · Asclepion-Meditec AG · Mar 8, 2002
K973498 — CYNOSURE PHOTOGENICA ER LASER · Cynosure, Inc. · Nov 13, 1997
K980361 — DERMABLATE ER: YAG LASER SYSTEM · Aesculap-Meditec North America · Apr 21, 1998

Submission Summary (Full Text)

{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