LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM

K063427 · Lynton Lasers Limited · GEX · Jul 25, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063427
• Device Name: LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM
• Applicant: Lynton Lasers Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LUMINA Intense Pulsed Light (& Laser) System is intended for use in applications requiring the selective ablation, vaporization and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialities of general & plastic surgery and dermatology.

Device Story

LUMINA Intense Pulsed Light (& Laser) System is a floor-standing platform for dermatological and surgical procedures. It comprises a main cabinet with central control electronics, a touchscreen interface, and interchangeable IPL handpieces or an internal Nd:YAG laser accessory. The system utilizes selective photothermolysis to target soft tissue, melanin, or vascular structures. The device is operated by clinicians in medical settings. The control unit manages timing and dosing parameters and includes a water-cooling system for handpieces. Clinicians use the touchscreen to configure treatment parameters based on the specific lesion or hair removal application. The output is delivered via light pulses to the patient's skin, affecting clinical decision-making by enabling non-invasive or minimally invasive tissue treatment. Benefits include the clearance of vascular/pigmented lesions, tattoo removal, and hair reduction.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, compliance with international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1), and comparison of technical specifications to the predicate device.

Technological Characteristics

Floor-standing cabinet with touchscreen control. Energy sources: Intense Pulsed Light (IPL) and Nd:YAG laser (1064nm and 532nm). Features water-cooling system for handpieces. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (laser safety), and IEC 60825-1 (laser radiation safety).

Indications for Use

Indicated for patients with Fitzpatrick skin types I-IV. IPL handpieces: treatment of benign pigmented epidermal lesions (dyschromia, hyperpigmentation, ephelides); benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma of Civatte, leg veins, venous malformations); and stable long-term/permanent hair removal. Nd:YAG 1064nm: treatment of benign vascular lesions (port wine stains, hemangiomas, telangiectasias, reticular leg veins, rosacea, venous lake, leg/spider veins, poikiloderma of Civatte, angiomas); removal of blue/black tattoos; non-ablative facial wrinkle treatment; hair removal/reduction; and pseudofolliculitis barbae. Nd:YAG 532nm: removal of light blue, yellow, and red tattoos; treatment of benign pigmented lesions (café au lait macules, lentigines, freckles, chloasma, nevi, nevus spillus, nevus of Ota, Becker's nevi).

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

• Lovely System (Lovely II, or "Harmony") (K033946, K042000)

Submission Summary (Full Text)

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K063427

## Appendix A11 The 510(k) Summary

. .

| Applicant & Submitter : | Lynton Lasers Limited | | JUL 25 2007 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Address : | Lynton House, Manor Lane,<br>Holmes Chapel, Cheshire, CW4 8AF, UK | | |
| Telephone : | [phone] | | |
| Fax : | [phone] | | |
| Contact Person : | Dr. Andrew J Berry<br>[e-mail] | | |
| Preparation Date : | 9th November 2006 | | |
| Device Submitted : | LUMINA Intense Pulsed Light (& Laser)<br>System | | |
| Common Name : | Light Therapy Device | | |
| Classification Name : | Laser surgical instrument for use in general<br>and plastic surgery and in dermatology. | | |
| Product Code : | GEX | | |
| Predicate Device : | Lovely System (Lovely II, or "Harmony"),<br>manufactured by MSq(M2) Ltd.<br>7 Haeshel St. P.O.B 3021<br>Caesarea Industrial Park, 38900 Israel<br>(K033946, K042000) | | |
| Device Description : | The LUMINA Intense Pulsed Light (& Laser)<br>System is a platform for a range of Intense<br>Pulse Light (IPL) Handpieces and an internal<br>Nd:YAG Laser Accessory for a number of<br>applications in general and plastic surgery and<br>dermatology, including :<br>Hair RemovalVascular Lesion treatmentsPigmented Lesion treatmentsTattoo removalFacial wrinkle reductionThe System includes : | | |

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- . A floor-standing main cabinet unit (including the central control electronics) that controls timing and dosing parameters. This unit also contains a water-cooling system used to remove heat from the IPL Handpieces and the internal Nd:YAG Laser Accessory (if fitted).
- A control and display panel including a ● touchscreen.
- A range of optional IPL handpieces that . include the flashlamp light source, electrical and cooling water connections.
- The LUMINA Intense Pulsed Light (& Laser) Intended Use : System is intended for use in applications requiring the selective ablation, vaporization and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialities of general & plastic surgery and dermatology.
- The LUMINA Intense Pulsed Light (& Laser) Indications for Use : stem, when using the IPL Handpieces, is indicated for :
- The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation and ephelides (freckles).
- The treatment of benign cutaneous . vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- The removal of unwanted hair and to effect . stable long-term or permanent hair removal.
- Indicated for use on all skin types (Fitzpatrick I-IV)

The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of :

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- . Benign vascular lesions such as, but not limited to treatment of :
- > Port wine stains
- > Hemangiomas

> Superficial and deep telangiectasias (venulectasias)

> Reticular veins (0.1 - 4.0mm diameter) of the leg

- > Rosacea
- > Venus Lake
- > Leg veins
- > Spider veins
- > Poikiloderma of Civatte
- > Angiomas
- . The removal of blue or black tattoos (significant reduction in the intensity of black and/or blue/black tattoos)
- The non-ablative treatment of facial ● wrinkles, such as, but not limited to: > Periocular wrinkles
- > Perioral wrinkles
- The removal of unwanted hair, for stable ● long-term or permanent hair reduction through selective targeting of melanin in
- hair follicles. Removal or lightening of unwanted hair . (with and without adjuvant preparation).
- Pseudofolliculitis barbae (PFB) .
- Indicated for use on all skin types . (Fitzpatrick I-IV)

The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 532nm (Long Pulsed and Q-Switched), is indicated for :

- Tattoo removal :
- > Light blue
- > Yellow
- > Red
- Benign pigmented lesions such as, but not . limited to :
- > Café au lait macules
- > Lentigines (senile and solar)
- > Freckles (ephelides)

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- > Chloasma
- > Nevi
- > Nevus spillus
- > Nevus of Ota
- > Becker's nevi
- The LUMINA Intense Pulsed Light (& Laser) Performance Data : System complies with the European Medical Devices Directive 93/42/EEC (Annex II) and the standards IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1
- Substantial Equivalence : The LUMINA Intense Pulsed Light (& Laser) System is substantially equivalent in terms of technological characteristics, performance, intended use, indications for use and operator interface to the previously cleared Lovely System (Lovely II, or "Harmony" System), cleared under K033946, K042000. There are no unique applications, indications, materials or specifications presented. Evidence of equivalence has been demonstrated through :
- · The LUMINA Intense Pulsed Light (& Laser) System's intended use and indications for use were previously cleared by the FDA for the predicate device.
- The technical characteristics of The LUMINA Intense Pulsed Light (& Laser) System are similar to those of the predicate device.
- Laser output values of the LUMINA Intense ● Pulsed Light (& Laser) System are similar to those of the predicate device (and other FDA cleared devices on the market)
- The predicate device, and other previously ● cleared devices with similar output specifications, have a proven safety and effectiveness in the treatment of the claimed indications.
- Safety and performance testing. .

Therefore, the LUMINA Intense Pulsed Light (& Laser) System is substantially equivalent to the predicate device cited above and raises no new safety and/or effectiveness issues.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract, overlapping shapes that resemble human profiles or waves, creating a sense of depth and movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2007

Lynton Lasers Ltd. % Dr. Andrew J. Berry Technical Director Lynton House, Manor Lane Holmes Chapel, Cheshire CW4 8AF United Kingdom

Re: K063427

Trade/Device Name: LUMINA Intense Pulsed Light (& Laser) System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgerv and in dermatology Regulatory Class: II Product Code: GEX Dated: June 21, 2007 Received: June 25, 2007

Dear Dr. Berry:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the 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 general controls provisions 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 comply 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

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Page 2 - Dr. Andrew J. Berry

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permitte your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 6338-241 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/suport/index20th11.

Sincerely yours,

Mark A. Millikusen

Mark N. Melkerson 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

510(k) Number (if known) : (063427

LUMINA Intense Pulsed Light (& Laser) System Device Name :

Indications for Use :

The LUMINA Intense Pulsed Light (& Laser) System is intended for use in applications requiring the selective ablation. vaporization and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialities of general & plastic surgery and dermatology, as follows :

The LUMINA Intense Pulsed Light (& Laser) System, when using the IPL Handpieces, is indicated for :

- . The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation and ephelides (freckles).
- The treatment of benign cutaneous vascular lesions including port wine . stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- The removal of unwanted hair and to effect stable long-term or . permanent hair removal.
- Indicated for use on all skin types (Fitzpatrick I-IV) .

Prescription Use V (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 IF NEEDED)

Mark N. Milliken

Division of General, Restorative, and Neurological Devices

510(k) Number K064327

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510(k) Number (if known) :K(063427

Device Name :

Indications for Use : - Continued from previous page -

The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of :

- Benign vascular lesions such as, but not limited to treatment of :
- > Port wine stains
- > Hemangiomas
- > Superficial and deep telangiectasias (venulectasias)
- > Reticular veins (0.1 4.0mm diameter) of the leg
- > Rosacea
- > Venus Lake
- > Leg veins
- > Spider veins
- > Poikiloderma of Civatte
- > Angiomas
- The removal of blue or black tattoos (significant reduction in the . intensity of black and/or blue/black tattoos)

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

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510(k) Number (if known) : (063427

Device Name :

Indications for Use : - Continued from previous page -

The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of - continued - :

- . The non-ablative treatment of facial wrinkles, such as, but not limited to:
- > Periocular wrinkles
- > Perioral wrinkles
- The removal of unwanted hair, for stable long-term or permanent hair . reduction through selective targeting of melanin in hair follicles.
- Removal or lightening of unwanted hair (with and without adjuvant preparation).
- Pseudofolliculitis barbae (PFB) ◆
- Indicated for use on all skin types (Fitzpatrick I-IV) ●

Prescription Use (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 IF NEEDED)

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510(k) Number (if known) :)(063427

Device Name :

Indications for Use : - Continued from previous page -

The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 532nm (Long Pulsed and Q-Switched), is indicated for :

- Tattoo removal : ●
- > Light blue = = =
- > Yellow
- > Red
- Benign pigmented lesions such as, but not limited to : �
- > Café au lait macules
- > Lentigines (senile and solar)
- > Freckles (ephelides)
- > Chloasma
- > Nevi
- > Nevus spillus
- > Nevus of Ota
- > Becker's nevi

Prescription Use (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 IF NEEDED)