VARILITE LASER SYSTEM

K041930 · Iridex Corporation · GEX · Sep 10, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041930
• Device Name: VARILITE LASER SYSTEM
• Applicant: Iridex Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 10, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The VariLite Laser System is intended for use in dermatological applications: The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for: - the treatment of vascular lesions including: Cherry Angiomas -Telangiectasia - Neovascularization Leg Veins - Port Wine Stains - Spider Angiomas Venous Lakes - Roscea - the treatment of benign pigmented lesions including: Freckles Lentigines - Poikloderma of Civatte Dermatosis Papulosis Nigra - Melasma Café- au- lait Stains - the treatment of cutaneous lesions including: Keratoses -Verruca - Skin Tags - the treatment of moderate inflammatory acne vulgaris. The 940 nm wavelength delivered with VariLite handpieces is indicated for: - the treatment of vascular lesions including: Cherry Angiomas Telangiectasia -. Neovascularization Leg Veins t Port Wine Stains Spider Angiomas - -Roscea - the treatment of benign pigmented lesions including: Lentigines - Dermatosis Papulosis Nigra - Café- au- lait Stains - hair removal .

Device Story

VariLite is a dual-wavelength (532 nm and 940 nm) medical diode laser system. Components include a laser console, footswitch, and fiber optic handpieces (manual or ScanLite Scanner). Used in clinical dermatology settings by physicians to treat vascular, pigmented, and cutaneous lesions, acne vulgaris, and for hair removal. Laser energy is delivered to the target tissue via handpieces; clinical effect is based on photothermal interaction with target chromophores. Output is controlled by the operator via the console interface. Benefits include non-invasive treatment of various skin conditions. The system is compatible with previously cleared DioLite 532 handpieces.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on non-clinical performance testing to applicable consensus and voluntary standards.

Technological Characteristics

Dual-wavelength diode laser system (532 nm and 940 nm). Components: laser console, footswitch, fiber optic handpieces (manual and ScanLite Scanner). Connectivity: compatible with existing DioLite 532 handpieces. Energy source: electrical power to diode laser. Sterilization: not specified (assumed standard for laser handpieces).

Indications for Use

Indicated for dermatological treatment of vascular lesions (telangiectasia, cherry angiomas, leg veins, neovascularization, spider angiomas, port wine stains, rosacea, venous lakes), benign pigmented lesions (lentigines, freckles, dermatosis papulosis nigra, poikiloderma of Civatte, café-au-lait stains, melasma), cutaneous lesions (keratoses, verruca, skin tags), moderate inflammatory acne vulgaris, and hair removal.

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

• DioLite 532 (K964074)
• Aura (K951034 /K024206)
• Prima KTP (K973828)
• Medilas D SkinPulse S (K003993)

Submission Summary (Full Text)

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04 1930 1/3

# 510(k) Summary IRIDEX Corporation VariLite Laser System

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

John Jossy IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 [phone] ext. 3016

SEP 1 0 2004

Contact Person: (same as above)

Date Prepared: May 27, 2004

#### Name of Device and Name/Address of Sponsor

VariLite Laser System

IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043

## Classification Name

Laser Instrument, Surgical, Powered CFR Section: 878.4810 Product Code: GEX

### Predicate Devices

The VariLite Laser System (VariLitc) is substantially equivalent to other currently legally marketed dermatology laser devices including those in the following table:

| Name | Manufacturer | 510(k) # |
|-----------------------|--------------------|------------------|
| DioLite 532 | IRIDEX Corporation | K964074 |
| Aura | Laserscope | K951034 /K024206 |
| Prima KTP | Nidek, Inc. | K973828 |
| Medilas D SkinPulse S | Dornier MedTech | K003993 |

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K041930 2/3

### Device Description

The VariLite is a dual wavelength medical diode laser source that delivers laser light at either 532 nm or 940 nm. Its main components are a laser console, footswitch, and a variety of fiber optic handpiece delivery devices, including manual handpieces and the ScanLite Scanner, which are all considered part of the VariLite Laser System. The VariLite console is also intended to be compatible with other delivery devices that have been the subject of previous 510(k) applications. These devices include DioLite 532 handpieces (K964074).

#### Intended Use/Indications for Use

The VariLite is intended for use in dermatological applications: The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for:

- the treatment of vascular lesions including: .
- Telangiectasia Cherry Angiomas - -Leg Veins Neovascularization - -Spider Angiomas Port Wine Stains -ﺳ -Roscea -Venous Lakes the treatment of benign pigmented lesions including: . Lentigines Freckles --Dermatosis Papulosis Nigra Poikloderma of Civatte -- Café- au- lait Stains -Melasma the treatment of cutaneous lesions including: . Verruca Keratoses ー -
- Skin Tags -

.

.

- the treatment of moderate inflammatory acne vulgaris. .
The 940 nm wavelength delivered with VariLite handpieces is indicated for:

- the treatment of vascular lesions including: Telangiectasia Cherry Angiomas --Leg Veins ﯩ Neovascularization -Spider Angiomas -Port Wine Stains -Roscea Venous Lakes ・ the treatment of benign pigmented lesions including: Lentigines --Freckles Dermatosis Papulosis Nigra Poikloderma of Civatte ---Café- au- lait Stains -Melasma
- hair removal .

#### Technological Characteristics and Substantial Equivalence

The VariLite is a dual wavelength diode laser which delivers laser light at the wavelengths of 532 nm and 940 nm.

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K041930 3/3

The IRIDEX Corporation DioLite 532 delivers a wavelength of 532 nm and is indicated for the treatment of vascular and pigmented lesions. Thus, it delivers the same wavelength and has similar indications to those of the VariLite.

The Laserscope Aura delivers laser light at a wavelength of 532 nm and is indicated for the treatment of vascular and pigmented lesions; for the treatment of cutaneous lesions: and for the treatment of acne vulgaris. Thus, it delivers the same wavelength and has similar indications to those of the VariLite.

The Nidek. Inc Prima KTP delivers laser light at a wavelength 532 nm and is indicated for the treatment of vascular and pigmented lesions and the treatment cutaneous lesions. Thus it delivers the same wavelength and has similar indications to those of the VariLite.

The Dornier MedTcch Medilas D SkinPulse S delivers laser light at a wavelength of 940 nm. It is indicated for the treatment of vascular and pigmented skin lesions and for hair removal. Thus it delivers the same infrared wavelength and has similar indications to those of the VariLite.

#### Non-Clinical performance Data

Non-clinical performance testing to applicable consensus and voluntary standards is demonstrated via a Declaration of Conformity.

### Clinical performance Data

Nonc

#### Conclusion

The VariLite is substantially equivalent to predicate devices currently legally marketed for the intended use/indications for use above.

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Image /page/3/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2004

Iridex Corporation c/o Mr. Daniel W. Lehtonen Staff Engineer – Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K041930

Trade/Device Name: VariLite Laser System 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: August 26, 2004 Received: August 27, 2004

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave rowled your your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreations of the enactment date of the Medical Device Amendments, or to conimered pror to ria) 2011-07-12, 2017 11:25 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may aller of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any i with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Daniel W. Lehtonen

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with and on. The FDA finding of substantial equivalence of your device to a legally premantee nevice results in a classification 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 it four attails office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marc Sacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost
C.S. - M.S. - Ph.D.

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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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K041930

Device Name: IRIDEX VarilLite Laser System____________________________________________________________________________________________________________________________________

Indications For Use:

.

-

The VariLite Laser System is intended for use in dermatological applications:

The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for:

- the treatment of vascular lesions including: ●
- Cherry Angiomas -Telangiectasia -
- Neovascularization ﮯ Leg Veins
- Port Wine Stains -
- Spider Angiomas Venous Lakes -
- Roscea ー the treatment of benign pigmented lesions including: .
- Freckles Lentigines --
- Poikloderma of Civatte Dennatosis Papulosis Nigra
- -Melasma Café- au- lait Stains ﺘ
- the treatment of cutaneous lesions including: .
- Keratoses -Verruca -
- Skin Tags -
- the treatment of moderate inflammatory acne vulgaris. .

The 940 nm wavelength delivered with VariLite handpieces is indicated for:

- the treatment of vascular lesions including: .
- Cherry Angiomas Telangiectasia -.
- Neovascularization Leg Veins t
- Port Wine Stains Spider Angiomas
- -Roscea ・
- the treatment of benign pigmented lesions including: .
- Lentigines -
- Dermatosis Papulosis Nigra -
- Café- au- lait Stains -
- hair removal .

Prescription Use _____________________________________________________________________________________________________________________________________________________________

-

OR (Per 21 CFR 801.109)

-

-

Over-The-Counter Use - - -

luation (ODE)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Venous Lakes

Poikloderma of Civatte

Freckles

Melasma

Concurrent

(Division Sign-Out)

Division of General, Restorative. and Neurological Devices

510(k) Number Kot/ 930