MULTIFUNCTIONAL SERIES

K131859 · Beijing Honkon Technologies Co., Ltd. · ONF · Oct 18, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131859
• Device Name: MULTIFUNCTIONAL SERIES
• Applicant: Beijing Honkon Technologies Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Oct 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in hair removal, moderate inflammatory acne vulgaris, and benign cutaneous vascular lesions.

Device Story

The Multifunctional Series (models Aeslight-S3D, HONKON-S3C, HONKON-M40e+, HONKON-M80e+) are Intense Pulsed Light (IPL) systems. The device delivers pulsed light energy (530nm-1200nm) via a sapphire handpiece to target chromophores based on the principle of selective thermolysis. By limiting pulse width below the thermal relaxation time of skin, the device causes thermal damage to targets while sparing surrounding tissue. The system is intended for use by clinicians in surgical, aesthetic, and cosmetic settings. Operators select specific filter/wavelength settings based on the condition (hair removal, acne, or vascular lesions) and skin type. The output energy and pulse parameters are controlled by the user to achieve therapeutic effects. The device benefits patients by providing non-invasive treatment for dermatologic conditions.

Clinical Evidence

Bench testing only. Performance testing verified output energy, spot size, and compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards. No clinical data provided.

Technological Characteristics

IPL system; sapphire crystal delivery; wavelength ranges 530-1200nm; energy range 20-50J/cm²; pulse duration 1-25ms; pulse delay 0.1-40ms; max power 1250-2000W; spot sizes 8x40mm and 15x60mm. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for hair removal, moderate inflammatory acne vulgaris, and benign cutaneous vascular lesions in patients with Fitzpatrick skin types I-V.

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

• Intense Pulsed Light (IPL) Systems (K122995)
• IPULSELIGHT IPL SYSTEM (K093627)

Submission Summary (Full Text)

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

S3 510(k) Summary

#### Project #:M0382013B

# Section #3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: ____

- 1. Date of Prepared: 06/07/2013

**OCT 18 2013**

2. Sponsor

Beijing Honkon Technologies Co., Ltd. No.3 Building, No.11 Yard, Kangding Street, BDA, 100176,Beijing, P.R.China

Establishment Registration Number: Not yet registered

Contact Person: Li Zhao Position: Management Representative Tel: [phone] ext. 508 Fax: [phone] ext. 610 Email: [e-mail]

- 3. Submission Correspondent
Diana Hong & Tarzan. Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]

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

S3 510(k) Summary

- 4. Proposed Device Identification
Proposed Device Name: Multifunctional Series Proposed Device Common Name: Intense Pulse Light (IPL)

Regulatory Information Classification Name: powered laser surgical instrument Classification: II; Product Code: ONF; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;

Intended Use Statement:

The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in hair removal, moderate inflammatory acne vulgaris, and benign cutaneous vascular lesions.

| Conditions | Filter setting<br>and<br>wavelength<br>scope | Skin type | | | | |
|---------------------|----------------------------------------------|-----------|----------|----------|----------|----------|
| | | I | II | III | IV | V |
| Hair<br>Removal | | 610-1200 | 610-1200 | 610-1200 | 610-1200 | 610-1200 |
| Acne | | 530-1200 | 530-1200 | 530-1200 | 530-1200 | 530-1200 |
| Vascular<br>Lesions | | 585-1200 | 585-1200 | 585-1200 | 585-1200 | 585-1200 |

- 5. Predicate Device Identification
510(k) Number: K122995 Predicate Device Name: Intense Pulsed Light (IPL) Systems Manufacturer: Beijing KES Biology Technology Co., Ltd.

510(k) Number: K093627 Predicate Device Name: IPULSELIGHT IPL SYSTEM Manufacturer: Shanghai APOLO Medical Technology Co., Ltd

- 6. Device Description

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

The Multifunctional Series device are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 530nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores" thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

IPL. Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penctration without using excessive energy levels and enables targeting of specific chromophores.

Based on this, The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic applications in hair removal, acne, and blood vessel lesions.

The proposed device includes four models as Aeslight-S3D, HONKON-S3C. HONKON-M40e+ and HONKON-M80e+.

#### 7. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- a) IEC 60601-1. Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988: Amendment i, 1991-11, Amendment 2, 1995.
- b) IEC 60601-1-2:2007. Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
- c) Performance Test (output energy, spot size)

#### 8. Technological Characteristics Comparison

The proposed device has the same technological characteristics with the predicate device, such as light medium, wavelength, control method and intended use.

- 9. Substantially Equivalent Conclusion Based on the comparison and analysis as following, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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

・・

| | | מערכת המועד היה היה להתנועד האור | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--|
| | Proposed Device | Predicate Device | Predicate Device | | |
| ITEM | Multifunctional Series | Intense Pulsed Light (IPL) | IPULSELIGHT IPL SYSTEM | Remark | |
| | | Systems(K 122995) | (K093627) | | |
| Product | | | | | |
| | ONF | ONF | ONF | SE | |
| Code | | | | | |
| Regulation | 21 CFR 878,4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | ટાને | |
| No | | | | | |
| Class | ll | ll | 11 | ટાદ | |
| Intended<br>Use | The Multifunctional<br>Series<br>(inclusive<br>device<br>of<br>the<br>handpiece used to deliver<br>pulsed-light<br>energy)<br>are<br>indicated for use in surgical,<br>aesthetic<br>and<br>cosmetic<br>applications in hair removal.<br>moderate inflammatory acne<br>vulgaris.<br>and<br>benign<br>cutaneous vascular lesions. | آل المحافظ من المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق<br>Intense Pulsed Light (IPL) S<br>(inclusive<br>ystems<br>of<br>the<br>handpiece used to deliver<br>energy )<br>pulsed-light<br>are<br>indicated for use in surgical,<br>aestheric<br>and<br>cosmetic<br>applications<br>in<br>permanent<br>hair reduction, treatment of<br>pigmented lesions, moderate<br>inflammatory acne vulgaris,<br>ephelides<br>(freckles),<br>and<br>vascular lesions. | IPulseLight IPL System (HS 300C,<br>HS 650) are identical with regard to<br>indications for use including<br>recommended filters to be used with<br>Fitzpatrick skin type, Both models<br>are intended for medical use in the<br>treatment of the following<br>dermatologic conditions:<br>Permanent hair reduction- long-term<br>stable reduction in number of hairs<br>re-growing after a treatment regiment<br>Treatment of:<br>- Moderate inflammatory acne<br>vulgaris<br>- Benign pigmented epidermal<br>lesions including dy schromia,<br>hyperpigmentation, melasma,<br>ephelides (freckles).<br>- Cutaneous lesions including scars<br>- Benign cutaneous vascular lesions<br>including port wine stains,<br>hemangiomas, facial, truncal and leg<br>telangiectasias, erythema of rosacea,<br>leg veins, spider anglomas and<br>venous malformations.<br>The integrated thermal cooling is<br>indicated for use in cooling the<br>epidermis at the treatment site prior<br>to, during, and after light treatment<br>in general aesthetic dermatologic and<br>plastic surgery procedures<br>· Reduce pain during light<br>treatment (via partial anesthesia from<br>cooling)<br>- Reduce discomfort during and/or<br>associated with light treatment<br>- Minimize thermal injury,<br>including thermal necrosis, to<br>non-larget skin and skin structures<br>during and/or associated with light<br>treatment, thus reducing possible<br>complications such as scabbing.<br>scarring, hyper - and/or hypo<br>pigmentation<br>- Allow the use of higher light or<br>laser fluencies for light treatments<br>(such as for hair removal and the<br>treatment of vascular or pigmented<br>lesions)<br>- Reduce potential side effects of<br>light treatments (such as for hair<br>removal and the treatment of<br>vascular or pigmented lesions) | ਟ ਦ | |
| ITEM | Proposed Device<br>Multifunctional Series<br>(Aeslight-S3D) | Predicate Device<br>Intense Pulsed Light (IPL)<br>Systems(K122995) | Predicate Device<br>IPULSELIGHT IPL SYSTEM<br>(K093627) | Remark | |
| Light source | Intense pulsed light | Intense pulsed light | Intense pulsed light | SE | |
| Wavelength | 610-1200nm,<br>585-1200nm,<br>530-1200nm | 430-1200nm, 530-1200nm,<br>640-1200nm,<br>Optional: 480-1200nm.<br>560-1200nm, 590-1200nm,<br>690-1200nm, 750 -1200nm | 420nm-1200, 510-1200nm,<br>560-1200nm, 610-1200nm,<br>640-1200nm (Standard):<br>480nm-1200, 585-1200nm,<br>690-1200nm, 755-1200nm<br>(Options) | Analysis<br>1 | |
| Deliver system | Sapphire | Sapphire | Sapphire | SE | |
| Energy Range | 20-50J/cm² | 10-60J/cm² | 10-60J/cm2 | Analysis<br>2 | |
| Pulse Delay | 0.1-40ms | 5 - 50ms | 5 - 50ms | Analysis<br>3 | |
| Pulse Duration | 1-25 ms | 1-20 ms | 2-20 ms | Analysis<br>4 | |
| Max. Power | 2000 W | 2000 W | 1200 W | SE | |
| Spot size | 8mm*40mm, 15mm*60mm | MED-210: 15mmX50mm<br>(optional: 12mmX33mm,<br>15mmX35mm )<br>MED-230:<br>A: 12mm X33mm;<br>B: 15mmX50mm (optional:<br>15mmX35mm) | 12x35mm, 15x50mm (Standard);<br>12x12mm, 12x25mm, 12x50mm,<br>15x35mm, 15x45mm (Options) | Analysis<br>5 | |
| Setting for Specified Indication for use:Hair Removal | | | | | |
| Wavelength<br>(nm) | 610-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | | |
| Energy Range<br>(J/cm2) | 20-50 | 10-44 | 10-46 | | |
| Pulse Duration<br>(ms) | 3-15 ms | 3-14 | 4-15 | Analysis<br>6 | |
| Pulse Delay<br>(ms) | 15-35 | 16-32 | 15-30 | | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X 33mm; 15mm X 50mm;<br>15mm X 35mm | 12mm X 25mm; 12mm X 35mm;<br>12mm X 50mm; 15mm X 45mm | | |
| Setting for Specified Indication for use: Acne | | |…