Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard intense pulsed light (IPL) system and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is indicated for use in surgical and aesthetic applications, including treatment for moderate inflammatory acne vulgaris and benign cutaneous vascular lesions, which are medical conditions, and it is a medical electrical equipment, suggesting a therapeutic intent.

Diagnostic

No

The device description and intended use indicate that the Multifunctional Series device is an intense pulsed light system used for therapeutic/cosmetic applications (e.g., hair removal, acne, vascular lesions) and not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "intense pulsed light system" and includes a "handpiece used to deliver pulsed-light energy," indicating it is a hardware device that delivers energy. The performance studies also focus on hardware aspects like output energy and spot size.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The intended uses listed are for surgical, aesthetic, and cosmetic applications performed on the patient (hair removal, acne, vascular lesions). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
Device Description: The description details an intense pulsed light system that works by applying light energy to the body. This is an external treatment device, not a device that analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

The device is clearly an external therapeutic/aesthetic device that uses light energy applied to the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

ONF

Device Description

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+.

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)

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)

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

Not Found

Predicate Device(s)

K122995, K093627

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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

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: +86 10 56370050 ext. 508 Fax: +86 10 56370067 ext. 610 Email: small@honkonlaser.com

1. Submission Correspondent
  Diana Hong & Tarzan. Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

1

S3 510(k) Summary

1. 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
and
wavelength
scope | Skin type | | | | |
|---------------------|----------------------------------------------|-----------|----------|----------|----------|----------|
| | | I | II | III | IV | V |
| Hair
Removal | | 610-1200 | 610-1200 | 610-1200 | 610-1200 | 610-1200 |
| Acne | | 530-1200 | 530-1200 | 530-1200 | 530-1200 | 530-1200 |
| Vascular
Lesions | | 585-1200 | 585-1200 | 585-1200 | 585-1200 | 585-1200 |

1. 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

1. 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.

1. 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

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		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
Use	The Multifunctional
Series
(inclusive
device
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.	آل المحافظ من المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق
Intense Pulsed Light (IPL) S
(inclusive
ystems
of
the
handpiece used to deliver
energy )
pulsed-light
are
indicated for use in surgical,
aestheric
and
cosmetic
applications
in
permanent
hair reduction, treatment of
pigmented lesions, moderate
inflammatory acne vulgaris,
ephelides
(freckles),
and
vascular lesions.	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 regiment
Treatment of:

Moderate inflammatory acne
vulgaris
Benign pigmented epidermal
lesions including dy schromia,
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)
Reduce discomfort during and/or
associated with light treatment
Minimize thermal injury,
including thermal necrosis, to
non-larget 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 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) | ਟ ਦ | |
| ITEM | Proposed Device
Multifunctional Series
(Aeslight-S3D) | Predicate Device
Intense Pulsed Light (IPL)
Systems(K122995) | Predicate Device
IPULSELIGHT IPL SYSTEM
(K093627) | Remark | |
| Light source | Intense pulsed light | Intense pulsed light | Intense pulsed light | SE | |
| Wavelength | 610-1200nm,
585-1200nm,
530-1200nm | 430-1200nm, 530-1200nm,
640-1200nm,
Optional: 480-1200nm.
560-1200nm, 590-1200nm,
690-1200nm, 750 -1200nm | 420nm-1200, 510-1200nm,
560-1200nm, 610-1200nm,
640-1200nm (Standard):
480nm-1200, 585-1200nm,
690-1200nm, 755-1200nm
(Options) | Analysis
1 | |
| Deliver system | Sapphire | Sapphire | Sapphire | SE | |
| Energy Range | 20-50J/cm² | 10-60J/cm² | 10-60J/cm2 | Analysis
2 | |
| Pulse Delay | 0.1-40ms | 5 - 50ms | 5 - 50ms | Analysis
3 | |
| Pulse Duration | 1-25 ms | 1-20 ms | 2-20 ms | Analysis
4 | |
| Max. Power | 2000 W | 2000 W | 1200 W | SE | |
| Spot size | 8mm40mm, 15mm60mm | MED-210: 15mmX50mm
(optional: 12mmX33mm,
15mmX35mm )
MED-230:
A: 12mm X33mm;
B: 15mmX50mm (optional:
15mmX35mm) | 12x35mm, 15x50mm (Standard);
12x12mm, 12x25mm, 12x50mm,
15x35mm, 15x45mm (Options) | Analysis
5 | |
| Setting for Specified Indication for use:Hair Removal | | | | | |
| Wavelength
(nm) | 610-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | | |
| Energy Range
(J/cm2) | 20-50 | 10-44 | 10-46 | | |
| Pulse Duration
(ms) | 3-15 ms | 3-14 | 4-15 | Analysis
6 | |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X 33mm; 15mm X 50mm;
15mm X 35mm | 12mm X 25mm; 12mm X 35mm;
12mm X 50mm; 15mm X 45mm | | |
| Setting for Specified Indication for use: Acne | | | | | |
| Wavelength
(nm) | 530-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Analysis
6 | |
| Energy Range | 20-50 | 10-40 | 10-42 | | |

Table 111-1 General Comparison

S3-4

4

S3 510(k) Summary

					Table III-2 Performance Comparison of model Aeslight-S3D
--	--	--	--	--	----------------------------------------------------------

5

K131859 Page 6 of 11

Premarket Notification 510(k) Submission

S3 510(k) Summary

(J/cm2)
Pulse Duration
(ms)	3-10	3-8	3-9
Pulse Delay
(ms)	15-35	16-32	15-30
Spot size	8mm X 40mm; 15mm X 60mm	12mm X33mm; 15mmX50mm
15mmX35mm	12x25mm, 12x35mm, 12x50mm,
15x35mm, 15x45mm
Setting for Specified Indication for use:vascular lesions
Wavelength
(nm)	585-1200	640-1200/690-1200/750-1200	610-1200/640-1200/690-1200
Energy Range
(J/cm2)	20-50	10-42	10-44
Pulse Duration
(ms)	3-10	3-8	3-9	Analysis
6
Pulse Delay
(ms)	15-35	16-32	15-30
Spot size	8mm X 40mm; 15mm X 60mm	12mm X33mm; 15mmX50mm
15mmX35mm	12x25mm,12x35mm, 12x50mm,
15x35mm, 15x45mm

Table III-3 Performance Comparison of model HONKON-S3C

| 17EM | Proposed Device
Multifunctional Series
(HONKON-S3C) | Predicate Device
Intense Pulsed Light (IPL)
Systems(K 122995) | Predicate Device
IPULSELIGHT IPL SYSTEM
(K093627) | Remark |
|-----------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Light source | Intense puised light | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | 6 10- 1 200nm,
585-1200nm,
530-1200mm | 430-1200nm, 530-1200nm,
640-1200mm,
Optional: 480-1200nm,
560-1200nm, 590-1200nm,
690-1200nm, 750 -1200nm | 420nm-1200, 510-1200mm,
560-1200nm, 610-1200nm,
640-1200nm (Standard):
480mm-1200, 585-1200mm,
690-1200nm, 755-1200nm
(Options) | Analysis

|
| Deliver system | Sapphire | Sapphire | Sapphire | SE |
| Energy Range | 20-50J/cm² | 10-60J/cm2 | 10-60J/cm2 | Analysis
2 |
| Pulse Delav | 0.1-40ms | 5 - 50ms | 5 - 50ms | Analysis
3 |
| Pulse Duration | 1-25 ms | 1-20 ms | 2-20 ms | Analysis
4 |
| Max Power | 2000 W | 2000 W | 1200 W | SE |
| Spot size | 8mm40mm, 15mm60mm | MED-210: 15mm X50mm
(optional: 12mmX33mm, | 12×35mm, 15×50mm (Standard);
12x12mm, 12x25mm, 12x50mm, | Analysis
5 |
| | | 15mmX35mm )
MED-230:
A: 12mm X33mm;
B: 15mmX50mm (optional:
15mmX35mm) | 15x35mm, 15x45mm (Options) | |
| | Setting for Specified Indication for use: Hair Removal | | | |
| Wavelength
(nm) | 610-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | |
| Energy Range
(J/cm2) | 20-50 | 10-44 | 10-46 | |
| Pulse Duration
(ms) | 3-15 ms | 3-14 | 4-15 | Analysis
6 |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X 33mm; 15mm X 50mm;
15mm X 35mm | 12mm X 25mm; 12mm X 35mm;
12mm X 50mm; 15mm X 45mm | |
| | Setting for Specified Indication for use:Acne | | | |
| Wavelength
(nm) | 530-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | |
| Energy Range
(J/cm2) | 20-50 | 10-40 | 10-42 | |
| Pulse Duration
(ms) | 3-10 | 3-8 | 3-9 | Analysis
6 |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm
15mmX35mm | 12x25mm,12x35mm, 12x50mm,
15x35mm, 15x45mm | |
| | Setting for Specified Indication for use:vascular lesions | | | |
| Wavelength
(nm) | 585-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | |
| Energy Range
(J/cm2) | 20-50 | 10-42 | 10-44 | |
| Pulse Duration
(ms) | 3-10 | 3-8 | 3-9 | Analysis
6 |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm
15mmX35mm | 12x25mm,12x35mm, 12x50mm,
15x35mm, 15x45mm | |
| ITEM | Proposed Device
Multifunctional Series
(HONKON-M40e+) | Predicate Device
Intense Pulsed Light (IPL)
Systems(K122995) | Predicate Device
IPULSELIGHT IPL SYSTEM
(K093627) | Remark |
| Light source | Intense pulsed light | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | 610-1200nm,
585-1200nm,
530-1200nm | 430-1200nm, 530-1200nm,
640-1200nm,
Optional: 480-1200nm.
560-1200nm. 590-1200nm,
690-1200nm, 750 -1200nm | 420nm-1200, 510-1200nm,
560-1200nm, 610-1200nm,
640-1200nm (Standard);
480nm-1200, 585-1200nm,
690-1200nm, 755-1200nm
(Options) | Analysis
1 |
| Deliver system | Sapphire | Sapphire | Sapphire | SE |
| Energy Range | 20-50J/cm² | 10-60J/cm² | 10-60J/cm² | Analysis
2 |
| Pulse Delay | 0.1-40ms | 5 - 50ms | 5 - 50ms | Analysis
3 |
| Pulse Duration | 1-25 ms | 1-20 ms | 2-20 ms | Analysis
4 |
| Max. Power | 1250 W | 2000 W | 1200 W | Analysis
7 |
| Spot size | 8mm40mm, 15mm60mm | MED-210: 15mmX50mm
(optional: 12mmX33mm,
15mmX35mm )
MED-230:
A: 12mm X33mm;
B: 15mmX50mm (optional:
15mmX35mm) | 12x35mm, 15x50mm (Standard);
12x12mm, 12x25mm, 12x50mm.
15x35mm, 15x45mm (Options) | Analysis
5 |
| | Setting for Specified Indication for use: Hair Removal | | | |
| Wavelength
(nm) | 610-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | |
| Energy Range
(J/cm2) | 20-50 | 10-44 | 10-46 | |
| Pulse Duration
(ms) | 3-15 ms | 3-14 | 4-15 | Analysis
6 |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X 33mm; 15mm X 50mm;
15mm X 35mm | 12mm X 25mm; 12mm X 35mm;
12mm X 50mm; 15mm X 45mm | |
| | Setting for Specified Indication for use: Acne | | | |
| Wavelength
(nm) | 530-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Analysis
6 |
| | | | | |
| Energy Range
(J/cm2) | 20-50 | 10-40 | 10-42 | |
| Pulse Duration
(ms) | 3-10 | 3-8 | 3-9 | |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm
15mmX35mm | 12x25mm,12x35mm,12x50mm,
15x35mm, 15x45mm | |
| Setting for Specified Indication for use:vascular lesions | | | | |
| Wavelength
(nm) | 585-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | |
| Energy Range
(J/cm2) | 20-50 | 10-42 | 10-44 | |
| Pulse Duration
(ms) | 3-10 | 3-8 | 3-9 | Analysis
6 |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm
15mmX35mm | 12x25mm,12x35mm,12x50mm,
15x35mm, 15x45mm | |

53-6

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S3 510(k) Summary

Project #:M0382013B

S3-7

7

S3 510(k) Summary

Table III-4 Performance Comparison of model HONKON-M40e+

S3-8

8

Table 111-5 Performance Comparison of model HONKON-M80e+

| ITEM | Proposed Device
Multifunctional Series
(HONKON-M80e+) | Predicate Device
Intense Pulsed Light (IPL)
Systems(K122995) | Predicate Device
IPULSELIGHT IPL SYSTEM
(K093627) | Remark |
|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Light source | Intense pulsed light | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | 610-1200nm,
585-1200nm,
530-1200nm | 430-1200nm, 530-1200nm,
640-1200nm,
Optional: 480-1200nm,
560-1200nm, 590-1200nm,
690-1200nm, 750-1200mm | 420nm-1200, 510-1200nm,
560-1200nm, 610-1200nm,
640-1200nm (Standard);
480nm-1200, 585-1200nm,
690-1200nm, 755-1200nm
(Options) | Analysis
1 |
| Deliver system | Sapphire | Sapphire | Sapphire | SE |
| Energy Range | 20-50J/cm2 | 10-60J/cm2 | 10-60J/cm2 | Analysis
2 |
| Pulse Delay | 0.1-40ms | 5 - 50ms | 5 - 50ms | Analysis
3 |
| Pulse Duration | 1-25 ms | 1-20 ms | 2-20 ms | Analysis
4 |
| Max. Power | 1250 W | 2000 W | 1200 W | Analysis
7 |
| Spot size | 8mm40mm, 15mm60mm | MED-210: 15mmX50mm | 12x35mm, 15x50mm (Standard); | Analysis |
| | | | 12x12mm, 12x25mm, 12x50mm,
15x35mm, 15x45mm (Options) | 5 |
| (optional: 12mmX33mm,
15mmX35mm )
MED-230:
A: 12mm X33mm;
B: 15mmX50mm (optional:
15mmX35mm) | | | | |
| Setting for Specified Indication for use:Hair Removal | | | | |
| Wavelength
(nm) | 610-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Analysis
6 |
| Energy Range
(J/cm2) | 20-50 | 10-44 | 10-46 | |
| Pulse Duration
(ms) | 3-15 | 3-14 | 4-15 | |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X 33mm; 15mm X 50mm;
15mm X 35mm | 12mm X 25mm; 12mm X 35mm;
12mm X 50mm; 15mm X 45mm | |
| Setting for Specified Indication for use:Acne | | | | |
| Wavelength
(nm) | 530-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Analysis
6 |
| Energy Range
(J/cm2) | 20-50 | 10-40 | 10-42 | |
| Pulse Duration
(ms) | 3-10 | 3-8 | 3-9 | |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm
15mmX35mm | 12x25mm, 12x35mm, 12x50mm,
15x35mm, 15x45mm | |
| Setting for Specified Indication for use:vascular lesions | | | | |
| Wavelength
(nm) | 585-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Analysis
6 |
| Energy Range
(J/cm2) | 20-50 | 10-42 | 10-44 | |
| Pulse Duration
(ms) | 3-10 | 3-8 | 3-9 | |
| Pulse Delay
(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm
15mmX35mm | 12x25mm, 12x35mm, 12x50mm,
15x35mm, 15x45mm | |

9

Project #:M0382013B

10

Analysis 1:

The wavelength range of proposed devices is very closed to that of predicate devices, the slight difference is considered to have no effect on effectiveness and safe.

Analysis 2:

The energy density of proposed devices is covered by the range of predicate devices, which is considered to have no effect on effectiveness and safe.

Analysis 3:

The pulse delay of proposed devices is covered by the range of predicate devices. which is considered to have no effect on effectiveness and safe.

Analysis 4:

The pulse duration of proposed devices is covered by the range of predicate devices, which is considered to have no effect on effectiveness and safe.

Analysis 5:

The spot size range of proposed devices is very closed to that of predicate devices, the slight difference is considered to have no effect on effectiveness and safe.

Analysis 6:

The setting of specified IFU of proposed device is very similar to that of predicate device, the difference is very slight, and only in the boundary value of the setting range. Therefore, the slight difference is considered to have no effect on effectiveness and safe.

Analysis 7:

The max. Input power of proposed devices is different with the predicate devices, all proposed devices meet the requirements of IEC 60601-1, So such different is considered to have no effect on effectiveness and safe.

11

Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Beijing Honkon Technologies Company, Ltd. % Ms. Diana Hong Shanghai Midlink Consulting Company, Ltd. P.O. Box 237-023 200030 Shanghai China

October 18, 2013

Re: K131859

Trade/Device Name: Multifunctional Series 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: ONF Dated: September 9, 2013 Received: September 19, 2013

Dear Ms. Hong:

We have reviewed vour 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.

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

12

Page 2 - Ms. Diana Hong

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 electronic 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

.fda.gov/MedicalDevices/ResourcesforYou/ucm400410.htm

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

13

K131859 Page 1 of 1

Premarket Notification 510(k) Submission E2 IFU Statement Project #:M0382013B

Indication for Use Statement

510(k) Number:

Device Name: Aeslight-S3D, HONKON-S3C, HONKON-M40e+ and HONKON-M80e+,

Indications for 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, noverate intlanmatory acne vulgaris, and benign cutancous vascular lesions.

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

& PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

.

O OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.10.18 12:04:12 -04'00'

for MXM

(Division Sign-Off)

Division of Surgical Devices

510(k) Number K131859

E2-2

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