MCL 29 DERMABLATE ERBIUM LASER SYSTEM

K964128 · Aesculap-Meditec GmbH · GEX · Mar 17, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964128
• Device Name: MCL 29 DERMABLATE ERBIUM LASER SYSTEM
• Applicant: Aesculap-Meditec GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral surgery, and ophthalmology (oculoplasty).

Device Story

MCL 29 Dermablate is an Er:YAG laser system (2.94 um wavelength) designed for soft tissue surgery. Device utilizes articulated arm for beam delivery; features adjustable spot sizes (1.6mm, 3mm, 5mm) and pulse parameters (350 usec pulse width; 5-15 Hz frequency; 100-800 mJ energy). System employs water/air heat exchanger for cooling and 635 nm diode aiming beam. Operated by clinicians in dermatology, plastic surgery, oral/maxillofacial surgery, and ophthalmology settings. Laser energy interacts with soft tissue to perform coagulation, vaporization, ablation, or cutting. Clinical benefit derived from precise tissue removal/modification during surgical procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and intended use similarity to legally marketed predicate devices.

Technological Characteristics

Er:YAG laser system; 2.94 um wavelength; 6 Watts max power; 350 usec pulse width; 5-15 Hz frequency; 100-800 mJ energy. Beam delivery via articulated arm. Cooling via water/air heat exchanger. 635 nm diode aiming beam. Power requirements: 220-240V or 100-120V, 50/60 Hz.

Indications for Use

Indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral and maxillofacial surgery, and ophthalmology (oculoplasty).

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

• Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser (K954013)
• Continuum Biomed, Inc., Multilite Erbium Laser System (K961748)

Submission Summary (Full Text)

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MAR 17 1997
K964128
ATTACHMENT A

# 510(k) SUMMARY

## MCL 29 DERMABLATE ERBIUM LASER SYSTEM

This 510(k) summary of safety and effectiveness for the MCL 29 Dermablate erbium laser system is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | AESCULAP-MEDITEC |
| --- | --- |
| Address: | 23832 Via Monte
Coto De Caza, CA 92679-4001 |
| Contact Person: | Mr. William T. Kelley
AESCULAP-MEDITEC
23832 Via Monte
Coto De Caza, CA 92679-4001 |
| Telephone: | 714-589-8536
714-589-6259 (Fax) |
| Preparation Date:
(of the Summary) | October 3, 1996 |
| Device Trade Name: | MCL 29 Dermablate Er:YAG Laser System |
| Common Name: | Erbium: Yttrium, Aluminum; Garnet (Er:YAG) Laser System |
| Classification Name | Laser surgical instrument for use in general and plastic surgery and in dermatology (see: 21 CFR 878.4810).
Product Code: GEX. |
| Legally marketed predicate devices | Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser;
Continuum Biomed, Inc., Multilite Erbium Laser System |
| Description of the Device: | The MCL 29 Dermablate laser is an erbium:YAG of power at 2.94um. See below for additional specifications. |
| Intended Use of the MCL 29 Dermablate laser: | The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic) |

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surgery), and in oral surgery, and ophthalmology (oculoplasty).

This intended use is the same or similar to that for the claimed predicate devices (see below).

Comparison of specifications of MCL 29 Dermablate and the claimed predicate devices:

| Specification | MCL 29 Dermablate Laser | TriLase 2940 Erbium Laser | Multilite Erbium Laser System |
| --- | --- | --- | --- |
| Type of laser | Er:YAG | Er:YAG | Er:YAG |
| Power | 6 Watts maximum | 5 Watts maximum | |
| Wavelength | 2.94 um | 2.94 um | 2.94 um |
| Pulse width | 350 usec | 300 usec
(option: continuous) | 100-400 usec |
| Frequency | 5-15 Hz | 5-20 Hz | 1-10 Hz |
| Spot size | 1.6mm, 3mm, 5mm | Focusing handpiece | |
| mJ energy | 100-800 mJ | 1 J/pulse maximum | 30 mJ min., 1 J max. |
| Beam delivery | Articulated arm | Articulated arm | Articulated arm |
| Cooling | Water/air heat exchanger | Internal heat exchanger | Internal heat exchanger |
| Aiming beam | 635 nm diode, 1 mW | 3 mW, red helium neon | 635 nm diode < 1 mW |
| Power requirements | 220-240V, 50/60 Hz
100-120V, 50-60 Hz | 220 VAC, 50/60 Hz | 120 VAC, 50/60 Hz |

## INDICATIONS

**Dermablate Laser:** The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral and maxillofacial surgery, and ophthalmology (oculoplasty).

**TriLase Laser:** The SEOMedical TriLase 2940 is indicated for use in small and large joint Arthroscopy, including microdiscectomies, endoscopic procedures and general surgical procedures for cutting (incision/excision), vaporizing and coagulating soft tissues. All soft tissues encountered in surgical procedures are included in this indication, such as, but not limited to, skin, subcutaneous tissue, striated and smooth tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes,

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organs and glands. Surgical specialties include dermatology, plastic surgery, general surgery, urology, gynecology, pulmonary surgery, gastroenterology, ENT, thoracic surgery, oral &amp; maxillofacial surgery, ophthalmology, and podiatry. (emphasis added)

Multilite Laser: The Multilite laser information includes "Cosmetic laser surgery...[is] primarily restricted to applications in dermatology, plastic surgery, and aesthetic surgery." (emphasis added)

Performance Data: None. The specifications and intended uses of the MCL 29 Dermablate laser are the same or very similar to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use.

Because of this, performance data were not required.

CONCLUSION: Based on the foregoing and other information in this application, AESCULAP-MEDITEC believes that the MCL 29 Dermablate laser is substantially equivalent to legally marketed predicate devices, i.e., the Schwartz Electro-Optics, Inc. TriLase 2940 erbium laser (K954013) and the Continuum Biomed, Inc. Multilite erbium laser system (K961748).

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