IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650

K093627 · Shanghai Apolo Medical Technologies Co., Ltd. · ONF · Jan 18, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K093627
• Device Name: IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
• Applicant: Shanghai Apolo Medical Technologies Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Jan 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

iPulseLight IPL System (HS 300C, HS 650) are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions: · Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen. · Treatment of: - Moderate inflammatory acne vulgaris . - Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, . melasma, ephelides (freckles). - . Cutaneous lesions including scars - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins, spider anglomas and venous malformations. The integrated thermal cooling is indicated for use in cooling the treatment site prior to, during, and after light treatment in general aesthetic dermatologic and plastic surgery procedures. - Reduce pain during light treatment (via partial anesthesia from cooling) .. - Reduce discomfort during and/or associated with light treatment . Minimize thermal injury, including thermal necrosis, to non-target skin and skin i s tructures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypo pigmentation Allow the use of higher light or laser fluencies for light treatments (such as for hair removal and the treatment of . vascular or pigmented lesions) Reduce potential side effects of light treatments (such as for hair removal and the treatment of vascular or pigmented i lesions)

Device Story

iPulseLight IPL System (HS 300C, HS 650) is an intense pulsed light (IPL) device emitting broadband light (420-1200 nm). Device utilizes selective photothermolysis to treat dermatologic conditions; integrated thermal cooling (TE cooler, circulating water/air) protects epidermis, reduces pain/discomfort, and mitigates thermal injury. Operated by clinicians in aesthetic/dermatologic settings via touch screen interface. Output parameters (10-50 J/cm2, 5-50 ms pulse duration) are selected based on skin type and condition. Cooling allows higher fluences for hair removal and vascular/pigmented lesion treatment. Benefits include non-ablative therapy, no downtime, and faster recovery compared to conventional therapies.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance specifications compared to the predicate device.

Technological Characteristics

Intense Pulsed Light (IPL) system; broadband light source (420-1200 nm). Energy: 10-50 J/cm2. Pulse duration: 5-50 ms. Cooling: Integrated TE cooler with circulating water and air. Delivery material: Sapphire. Interface: Touch screen. Accessories: Foot switch, protection glasses/goggles. Power: 1200W. Classification: Class II, 21 CFR 878.4810.

Indications for Use

Indicated for permanent hair reduction, treatment of moderate inflammatory acne vulgaris, benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides), cutaneous lesions (scars), and benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, leg veins, spider angiomas, venous malformations). Integrated cooling indicated for pain/discomfort reduction and thermal injury mitigation during light treatment. Applicable to Fitzpatrick skin types I-V; skin type VI excluded.

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

• Accelawave System (K082484)

Submission Summary (Full Text)

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K043627 p. 1 of 3

### 510(K) SUMMARY

#### [as required by 807.92(c)]

JAN 1 8 2011 .

A.510k Number:

B. Applicant: C ompany name: PATS CORP Address: 49 Candlewood Way, Buena Park, CA 90621, USA Phone: [phone] FAX: [phone]

C. Proprietary and Established Names: Shanghai APOLO Medical Technology Co., Ltd Address: 3/F, Building A. No. 388, Yindu Road, Xuhui District,Shanghai, China Tel: [phone] Fax: [phone]

D. Regulatory Information

Common Name: Intense Pulsed Light (IPL) system.

Classification name: Laser surgical instrument for use in general and plastic surgery and

in dermatology (21 CFR Part 878.4810).

Device classification: Class II. Product code: GEX

## E. Intended use

iPulseLight IPL System (HS 300C, HS 650) are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:

· Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen.

· Treatment of:

- Moderate inflammatory acne vulgaris .
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, . melasma, ephelides (freckles).
- . Cutaneous lesions including scars
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins,

spider anglomas and venous malformations.

The integrated thermal cooling is indicated for use in cooling the treatment site prior to, during, and after light treatment in general aesthetic dermatologic and plastic surgery procedures.

- Reduce pain during light treatment (via partial anesthesia from cooling) ..
- Reduce discomfort during and/or associated with light treatment .

Minimize thermal injury, including thermal necrosis, to non-target skin and skin i s tructures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypo pigmentation

Allow the use of higher light or laser fluencies for light treatments (such as for hair removal and the treatment of . vascular or pigmented lesions)

Reduce potential side effects of light treatments (such as for hair removal and the treatment of vascular or pigmented i lesions)

#### F. Description

iPulseLight IPL System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. With these special properties, the IPL has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption and photothermolysis of light sources. Meanwhile, IPL treatment is more effective, with no downtime and can make the patients get recovered more quickly than conventional therapies.

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K.093627

20 P.

## G. Substantial Equivalence Information

Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology (per 21 CFR Part 878.4810).

Device classification: C lass II. Product code: GEX Predicate devices: Accelawave System (K082484)

## Comparison of Ellipse I PL to predicate devices:

| | iPulse Li ght IP L ( HS- 650 & H S-300C) | Accelawave S ystem | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| 510(k) reference | Current submission | K082484 | | | | |
| Technology/ | Intense Pulsed Light | Intense Pulsed Light | | | | |
| Operation/ | (IPL)/broad spectrum | (IPL)/broad spectrum | | | | |
| Device | light/touch screen | light/touch screen | | | | |
| description | operation. | operation. | | | | |
| | | | | | | |
| Intended Use ( wa | iPulseLight IPL System (HS 300C, HS 650) are identical | Accelawave System is identical with regard to indications for | | | | |
| velength/ E nergy | with regard to indications for use including recommended | use including recommended filters to be used | | | | |
| see at tachment t ab | filters to be used with Fitzpatrick skin type. Both models<br>are intended for medical use in the treatment of the | with Fitzpatrick skin type. Both models are intended for<br>medical use in the treatment of the following dermatologic | | | | |
| le) | following dermatologic conditions: | conditions: | | | | |
| | · Permanent hair reduction- long-term stable reduction in | · Permanent hair reduction- long-term stable reduction in | | | | |
| | number of hairs re-growing after a | number of hairs re-growing after a | | | | |
| | treatment regimen.<br>Treatment of: | treatment regimen.<br>· Treatment of: | | | | |
| | Moderate inflammatory acne vulgaris<br>- | - Moderate inflammatory acne vulgaris | | | | |
| | Benign pigmented epidermal lesions including | - Benign pigmented epidermal lesions including dyschromia, | | | | |
| | dyschromia, hyperpigmentation,<br>melasma, | hyperpigmentation, melasma, ephelides | | | | |
| | ephelides (freckles).<br>Cutaneous lesions including scars | (freckles).<br>- Cutaneous lesions including scars | | | | |
| | Benign cutaneous vascular lesions including port | - Benign cutaneous vascular lesions including port wine stains, | | | | |
| | wine stains, hemangiomas, facial, truncal and leg | hemangiomas, facial, truncal and leg | | | | |
| | telangiectasias, erythema of rosacea, leg veins. | telangiectasias, erythema of rosacea, leg veins and venous | | | | |
| | spider anglomas and venous malformations. | malformations. | | | | |
| | The integrated thermal cooling is indicated for use in | The integrated thermal cooling is indicated for use in cooling<br>the epidermis at the treatment site prior to, during, | | | | |
| | cooling the epidermis at the treatment site prior to, during, | and after light treatment in general aesthetic dermatologic and | | | | |
| | and after light treatment in general aesthetic dermatologic | plastic surgery procedures. | | | | |
| | and plastic surgery procedures.<br>Reduce pain during light treatment (via partial<br>- | - Reduce pain during light treatment (via partial anesthesia<br>from cooling) | | | | |
| | anesthesia from cooling) | - Reduce discomfort during and/or associated with light | | | | |
| | Reduce discomfort during and/or associated with light | treatment | | | | |
| | treatment | - Minimize thermal injury, including thermal necrosis, to | | | | |
| | Minimize thermal injury, including thermal necrosis,<br>(<br>to non-target skin and skin<br>structures during | non-target skin and skin s tructures during and/or<br>associated with light treatment, thus reducing possible | | | | |
| | and/or associated with light treatment, thus reducing | complications such as scabbing, scarring, hyper - | | | | |
| | possible complications such as scabbing, scarring, hyper - | and/or hypo pigmentation | | | | |
| | and/or hypo pigmentation | - Allow the use of higher light or laser fluencies for light | | | | |
| | Allow the use of higher light or laser fluencies for light<br>,<br>treatments (such as for hair removal and the treatment of | treatments (such as for hair removal and the treatment<br>of vascular or pigmented lesions) | | | | |
| | vascular or pigmented lesions) | - Reduce potential side effects of light treatments (such as for | | | | |
| | Reduce potential side effects of light treatments (such | hair removal and the treatment of vascular or | | | | |
| | as for hair removal and the treatment of vascular or | pigmented lesions) | | | | |
| | pigmented lesions) | | | | | |
| Wavelength Range | 420-1200 nm | 420-1200 nm | | | | |
| Energy ouput/ | 10-50 J/cm 2 | 10-50 J/cm 2 | | | | |
| Setting Range | | | | | | |
| Pulse duration | 5-50 ms | 5-50 ms | | | | |
| Output Mode | Pulse method | Pulse method | | | | |
| Pulse width | 2-20 ms | 2-15 ms | | | | |
| Accessories | Foot switch | Foot switch | | | | |
| | Protection glasses | Protection glasses | | | | |
| | Protection goggles | Protection goggles | | | | |
| Deliver Materials | sannhire | sannhire | | | | |

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K093627 p. 385

| | 1200W | 1200W |
|-------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Max.power<br>consumption | | |
| Applicator/hand-<br>piece spot size | 12x35mm and 15x 50mm | 15x45mm |
| Charge time/<br>Repeat rate | 1.5-2.0 Sec. | 1.5-2.0 Sec. |
| Cooling method | Cooling handpiece by TE co oler an d<br>Circulating water & Air | Cooling handpiece by TE co oler an d<br>Circulating water & Air |
| Device<br>classification | II; 21 CFR 878.4810, GEX | II; 21 CFR 878.4810, GEX |

use for Treatment region and dose rate.
The UDI - Sustem(HS-650,HS-300C)

| Intended use for iPulse Light IPL System(HS-650,HS-300C) | | | | | | SKIN TYPES | | | | | |
|----------------------------------------------------------|----------|----------|----------|----------|----------|------------|--|--|--|--|--|
| CONDITIONS | I | II | III | IV | V | VI | | | | | |
| Hair(course) | 610~1200 | 610~1200 | 610~1200 | 640~1200 | 690~1200 | N/A | | | | | |
| Hair(fine) | 420-1200 | 420-1200 | 420~1200 | 510~1200 | 560-1200 | N/A | | | | | |
| Acen Vulgaris | | | | | | N/A | | | | | |
| Pigmented Epidermal<br>Lesions | 510-1200 | 510~1200 | 510-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| a) Dyschromia | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| b)Hyperpigmentation | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| c)Melasma | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| d) Ephelides | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| Cutaneous Lesions | | | | | | | | | | | |
| Scars | | | | | | | | | | | |
| Cutaneous Vascular<br>Lesions | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| a) Port Wine Stain (Child) | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| b) Port Wine Stain (Adult) | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| c) Hemangiomas | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| d) Telaugiectasias | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| e) Rosacea | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| f) Spider Anglomas | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| g) Venous Malformations | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| Leg Veins | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| a) Small | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |
| b) Medium | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | | | | | |

stem (HS-650, HS-300C)"

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perform.

H. Performance Characteristics (If/when applicable)
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{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

## JAN 1 8 2011

Shanghali Apolo Medical Technologies Co., Ltd. % Mr. Brandon Choi Authorized Agent, General Manager 49 Candlewood Way Buena Park, CA 90621

Re: K093627

Trade/Device Name: Ipulselight IPL System, Models HS 300C and HS 650 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONF Dated: January 06, 2011 Received: January 11, 2011

Dear Mr. Choi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

and the country of the county of the

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

Page 2 - Mr. Brandon Choi

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections. 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for
Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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-K093627

e. l.öfz

# Indications for Use

510(k) Number (if known):

Device Name: iPulseLight IPL System (HS 300C, HS 650)

Indications For Use:

iPulseLight IPL System (HS 300C, HS 650) are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:

· Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen.

· Treatment of:

- Moderate inflammatory acne vulgaris ।
- Benian pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles).
- Cutaneous lesions including scars -
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins, spider anglomas and venous malformations.

The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light treatment in general aesthetic dermatologic and plastic surgery procedures.

- Reduce pain during light treatment (via partial anesthesia from cooling) เ
- Reduce discomfort during and/or associated with light treatment ı
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypo pigmentation
- Allow the use of higher light or laser fluencies for light treatments (such as for hair i removal and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light treatments (such as for hair removal and the treatment of vascular or pigmented lesions)

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K093627

p. 20 A 2

JAN 1 8 2011

| | | | | SKIN TYPES | | | |
|----------------------------|-----------------------------|----------|----------|------------|-----------|----------|-----|
| CONDITIONS | | 1 | 테 | हा | ાિ | V | VI |
| Hair(course) | | 610~1200 | 610~1200 | 610~1200 | 640~1200 | 690~1200 | N/A |
| Hair(fine) | | 610~1200 | 610~1200 | 610-1200 | 640~ 1200 | 690-1200 | NIA |
| Acne Vulgaris | | 420~1200 | 420-1200 | 420~1200 | 510~1200 | 560~1200 | NIA |
| Pigmented Epidermal | | | | | | | |
| Lesions | | | | | | | |
| a)Dyschromia | ורדה | 510~1200 | 510-1200 | 510~1200 | 560~1200 | 560~1200 | N/A |
| Hyperpigmentation | | 510-1200 | 510~1200 | 510~1200 | 560~1200 | 560~1200 | N/A |
| c)Melasma | | 560~1200 | 560~1200 | 560~1200 | 560~1200 | 560~1200 | N/A |
| d)Ephelides | | 560~1200 | 560~1200 | 560~1200 | 560~1200 | 560~1200 | NA |
| Cutaneous Lesions | | | | | | | |
| Scars | | 560~1200 | 560~1200 | 560~1200 | 560~1200 | 560~1200 | |
| Cutaneous Vascular | | | | | | | |
| Lesions | | | | | | | |
| a) Port Wine Stain (Child) | AAR HTONETEVAN DUE SOMITTES | 510~1200 | 510~1200 | 510~1200 | 560~1200 | 560~1200 | ALC |
| b) Port Wine Stain (Adult) | | 510~1200 | 510~1200 | 510~1200 | 560~1200 | 560~1200 | NA |
| c) Hemangiomas | | 560~1200 | 560~1200 | 560~1200 | 550~1200 | 560~1200 | N/A |
| d) Telaugiectasias | | 510~1200 | 510~1200 | 510~1200 | 560~1200 | 560~1200 | N/A |
| e) Rosacea | | 560~1200 | 560~1200 | 560~1200 | 560~1200 | 560~1200 | N/A |
| f) Spider Anglomas | | 560~1200 | 560~1200 | 580-1200 | 560~1200 | 560~1200 | NA |
| g) Venous Malformations | | 560~1200 | 560~1200 | 560~1200 | 560~1200 | 560~1200 | NA |
| Leg Veins | | | | | | | |
| a) Small | | 510-1200 | 510~1200 | 510-1200 | 560~1200 | 560~1200 | N/A |
| b) Medium | | 560~1200 | 560~1200 | 560~1200 | 560~1200 | 560~1200 | NA |
| c) Large | | 560~1200 | 560~1200 | 560~1200 | 560~1200 | NA | N/A |
| | | | | | | | |

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)

штановнымичный иштемии инининин иматичинии и иматимии и имаан имальным интеменным и

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ohm

(Division Sign-Off) ( ( Crision Sign-Off)
Division of Surgical, Orthopedic.
and Restorative Devices and Resion of Surgical, Ort
and Restorative Devices

510(k) Number L093627