DEALIGHT IPL

K043032 · Europro, Inc. · GEX · Jul 19, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043032
• Device Name: DEALIGHT IPL
• Applicant: Europro, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dealight Intense Pulsed Light (IPL) is indicated for use in surgical applications requiring selective photohermolysis (photocoagulation or coagulation) and hemostasis of soft tisse in the medical specialties of general and plastic surgery, and dermatology. Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for: - The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. 1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.

Device Story

Dealight IPL system; console with control electronics/software; display panel; air cooling system; hand-piece with cut-off filters. Emits intense pulsed light (590-1200 nm) to target melanin in hair follicles for hair reduction or to achieve soft tissue coagulation/hemostasis. Operated by clinicians in medical settings. Output used for visual guidance and treatment delivery; affects clinical decision-making by enabling non-invasive dermatological and surgical procedures. Benefits include stable long-term hair reduction and controlled tissue coagulation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technical specifications and performance characteristics compared to predicate device.

Technological Characteristics

IPL system; wavelength range 590-1200 nm; air cooling system; hand-piece with cut-off filters; console-based; conforms to 21 CFR 1040.10 and 1040.11.

Indications for Use

Indicated for removal of unwanted hair and long-term/permanent hair reduction in skin types I-V; indicated for surgical applications requiring selective photothermolysis, photocoagulation, and hemostasis of soft tissue in general surgery, plastic surgery, and dermatology.

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

• Lumenis's/ESC Family of IPL systems (K030342)

Submission Summary (Full Text)

{0}------------------------------------------------

K043032

### 510 (k) Summary

| Oct. 18, 2004 | Greg Kennebeck – Contact<br>Europro, Inc.<br>3952 Camino Ranchero Rd.<br>Camarillo, CA 93012<br>Phone: [phone]<br>Fax: [phone] |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Dealight IPL |
| Common Name: | Laser Powered Surgical Instrument |
| Regulation #: | 878.4810 |
| Regulatory Status: | Class II |
| Product Code: | GEX |

## PRODUCT DESCRIPTION

The Dealight Intense Pulsed Light (IPL) is comprised of the following main components:

- A light / laser system console (including software and control electronics) -
- A control and display panel -
- Air cooling system -
- A hand-piece with cut off filters -

## INTENDED USE

The Dealight Intense Pulsed Light (IPL) is indicated for use in surgical applications requiring selective photohermolysis (photocoagulation or coagulation) and hemostasis of soft tisse in the medical specialties of general and plastic surgery, and dermatology.

Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for:

- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
¹ Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.

{1}------------------------------------------------

K04 3032

2/

# Rationale for Substantial Equivalence

The Dealight is substantial equivalent to Lumenis's/ESC Family of IPL' systems (K030342). The Dealight is comparable to the predicate device in terms of the technical specifications, operating performance features, general physical configuration and intended uses.

# Safety and Effectiveness Information

The Dealight conforms with federal regulations and performance standards 21 CFR 1040.10 and 21 CFR 1040.11 for medical laser systems.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2005

Mr. Greg Kennebeck Europro, Inc. 3952 Camino Ranchero Road Camarillo, California 93012

Re: K043032 Trade/Device Name: Dealight IPL Regulation Number: 21 CFR 878.4810 Regulation Name: 21 Crise of 21 Crise of 2018 - 12:00
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 10, 2005 Received: June 14, 2005

Dear Mr. Kennebeck:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your becaon 910(tr) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the clerosuly to regally manage of the Medical Device American of the Federal Food. Days commerce provision to May 20, 1978, the exactions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, ulciclefore, market the device, books of the more of registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinod (600 above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 issualled or our device complies with other requirements of the Act that I DA has made a doternations administered by other Federal agencies. You must of any it catal statutes and regulations and and limited to: registration and listing (21 Comply will an the 71et 51equirements)01); good manufacturing practice requirements as set CITY art 807), adeimig (21 CFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 – Mr. Greg Kennebeck

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailtoning of substantial equivalence of your device to a legally premarket notification: "The PPF intelligention 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 Jour as 10 1) 276-01 15. Also, please note the regulation entitled, Conlect the Office of Compunation at (21 t 7 = 1 = = = 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small biller general international and Consumer Assistance at its toll-free number [phone] or Manufacturers; International and Oction: http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

to-lit

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# INDICATIONS FOR USE

K043032 510 (k) Number: Dealight IPL Device Name:

· · · · · · .

Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for:

- The removal of unwanted hair from all skin types, and to effect stable long-term, -The removed of an wadestion in skin types I-V through selective targeting of melanin in hair follicles.
Prescription Use 2 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Euch R

of Of General, Restorative Nemolorical Devic

K043032