LAD (EPITURE EASYTOUCH), MODEL LAD-08

K033962 · Norwood Abbey , Ltd. · GEX · Feb 20, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033962
• Device Name: LAD (EPITURE EASYTOUCH), MODEL LAD-08
• Applicant: Norwood Abbey , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

LAD-08 is indicated for ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.

Device Story

The Epiture™ Easytouch (Model LAD-08) is a portable, handheld, battery-powered laser surgical instrument. It emits radiant energy at a wavelength of 2.94 µm with a 6 mm spot size at the treatment site. The device is designed to remove the stratum corneum of the skin. By ablating the outer layer of the skin, the device facilitates the subsequent application of OTC topical 4% lidocaine cream for local dermal anesthesia. It is intended for use in clinical settings.

Clinical Evidence

No clinical studies were performed for the LAD-08; bench testing only.

Technological Characteristics

Portable, handheld, battery-powered laser surgical instrument. Wavelength: 2.94 µm. Spot size: 6 mm. Product code: GEX. Regulation: 21 CFR 878.4810.

Indications for Use

Indicated for ablation of the outer layer of the skin in patients requiring local dermal anesthesia prior to the application of OTC topical 4% lidocaine cream.

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

• LAD-01/06

Submission Summary (Full Text)

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#### 510(k) Summary of Safety And Effectiveness for Model LAD-08 13.

| 13.1 Submitter Information | FEB 2 0 2004 |
|-------------------------------|--------------|
| Norwood Abbey Limited. | |
| 63 Wells Road | |
| Chelsea Heights Victoria 3196 | |
| Australia | |

| Contact Person: | Paul Clark |
|-----------------|-----------------|
| Telephone No.: | [phone] |
| Fax: | [phone] |

#### 13.2 Device Name

Laser surgical instrument for general and plastic surgery and in Classification Name: dermatology

LAD, model LAD-08 Proprietary Name:

## 13.3 Predicate Devices

LAD-01/06

# 13.4 Description of the Device

The Norwood Abbey Model LAD-08 is a portable, handheld, battery powered bern hismater The Norwood Abbey Model LAD-60 is a portuois, handelength of 2.94 um and a beam diameter of I he radiant energy produced by thin itsel mas a m.
spot-size of 6 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.

# 13.5 Intended Use

The intended use of the LAD-08 is for ablation of the outer layer of the skin prior to the The meended use of the EAD oo in roller and the cream, for local dermal anesthesia.

# 13.6 Clinical Studies

No additional studies have been performed on the LAD-08.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2, 0 2004

Mr. Paul Clark Quality and Regulatory Affairs Manager Norwood Abbcy Limited 63 Wells Road Chelsea Heights Victoria 3196 Australia

Re: K033962 Trade/Device Name: Epiture™ Easytouch, Model LAD-08 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 18, 2003 Received: December 22, 2003

Dear Mr. Clark:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is retty pe issubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tor use stated in the encrosure) to regars the Medical Device Amendments, or to comments provide to May 20, 1978, the enable with the provisions of the Federal Food, Drug, devices mat have been reculsentied in assee approval of a premarket approval application (PMA). alla Cosmetic Act (Act) that do not require appt to the general controls provisions of the Act. The r ou may, mercere, manver the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sce above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soo aoove) the existing major regulations affecting your device can may be subject to subli ductional venisons, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obancements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that ITA has made a determinations administered by other Federal agencies. You must of any irederal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, and manufacturing practice requirements as set CFK Part 677), labeling (21 CFR Part 820); and if applicable, the electronic (200); and if applicable, the electronic (200 forth in the quality bytichly (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Paul Clark

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your article quivalence of your device to a legally premarket notification. The PDA midner of basification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your active of the collection of the regulation entitled, Contact the Office of Complance at (301) ->>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> "Misbranding by relevence to premation notification of the Act from the Division of Small other general information on your responsion.com at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-ifremation http:// Manufacturers, International and Combailer Prosservedrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Mikkelson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 3.2 Statement of Intended Use

Page __ of

510(k) Number (if known): K033962

Device Name: Epiture™ Easytouch, Model LAD-08

## Indications for Use:

LAD-08 is indicated for ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use

Mark N Millkum

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

03391

510(k) Number_