Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard IPL system and its intended uses, focusing on light-based therapies and cooling. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, treatment planning, or other functions.

Therapeutic

Yes
The device is intended for medical use in the treatment of various dermatologic conditions, including moderate inflammatory acne vulgaris, benign pigmented epidermal and cutaneous lesions, and benign cutaneous vascular lesions. These are medical conditions that require treatment, qualifying the device as therapeutic.

Diagnostic

No

The device is described as an IPL system intended for medical treatment of various dermatological conditions, such as hair reduction, acne, pigmented lesions, and vascular lesions. It does not mention any diagnostic capabilities.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a hardware system (Intense Pulsed Light source) with a specific wavelength spectrum, not a software-only application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
Device Function: The iPulseLight IPL System is described as an intensive, broadband, coherent light source used for treating various dermatologic conditions on the skin. It directly interacts with the patient's body.
Intended Use: The intended uses listed are all therapeutic procedures performed directly on the patient's skin (hair reduction, treatment of acne, lesions, vascular conditions).
Device Description: The description focuses on the light source and its application to skin tissue.
Lack of IVD Indicators: There is no mention of analyzing samples, performing laboratory tests, or providing diagnostic information based on bodily fluids or tissues.

Therefore, the iPulseLight IPL System is a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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
- 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 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)

Product codes (comma separated list FDA assigned to the subject device)

GEX, ONF

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082484

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

0

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: 714-523-1592 FAX: 714-523-1592

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: +86-21-3462 2842 Fax: +86-21-3462 2840

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.

1

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
are intended for medical use in the treatment of the	with Fitzpatrick skin type. Both models are intended for
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.
Treatment of:	treatment regimen.
· Treatment of:
	Moderate inflammatory acne vulgaris

                                                                                | - Moderate inflammatory acne vulgaris                                                                                   |  |  |  |  |

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
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.
Reduce pain during light treatment (via partial

                                 | - Reduce pain during light treatment (via partial anesthesia

2

K093627 p. 385

	1200W	1200W
Max.power
consumption
Applicator/hand-
piece spot size	12x35mm and 15x 50mm	15x45mm
Charge time/
Repeat rate	1.5-2.0 Sec.	1.5-2.0 Sec.
Cooling method	Cooling handpiece by TE co oler an d
Circulating water & Air	Cooling handpiece by TE co oler an d
Circulating water & Air
Device
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
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
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)"

teristics of the iPulse Light II, LED's, that the pertinent characteristi

195-60. of Present in:
Concludios of the interiminal characteristics of the Press. Internent of this concerners of the President on the President of the President of the Primer of Pr Conclusion:
A companison of the indical characteristics of the Propention In Line Collection C
A comprison of the Accelanes System, led onte oncludes Conclusion of the indival characeae.
A computer died devel be Acelana o System. Ind to the concuision .

the iPulse Light IPL system is substantially equivalent to device approved.
IPL System is substantially equivalent of safety or efficacy.
performance or raise new questions

IPL System to

a chance or raise new

perform.

H. Performance Characteristics (If/when applicable)
H. Performance wolies with the European Medical Director I Performance Characteristics (It/when appean Medical Prestive
The device complies with the European Medical devices, and the county of the complies 4. Performance Characterisatis (1) - 1.
The device complies with the European Medical Directive
Standards: 93/42/EEC conceming medical devices, and will comply with
enting ar

. Performance Start - 1 - 1 - European Medical Direct - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

:

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 (800) 638-2041 or (301) 796-7100 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

5

-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)

6

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