(116 days)
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.
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+.
The provided 510(k) summary (K131859) describes a Substantial Equivalence (SE) determination for the Multifunctional Series IPL device. This type of submission relies on comparing the new device to existing legally marketed predicate devices rather than conducting new clinical studies to prove efficacy and safety from scratch.
Here's an analysis of the provided information concerning acceptance criteria and supporting evidence:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. This means that the proposed device must be as safe and effective as the predicate device(s) and have similar technological characteristics and intended use. The "acceptance criteria" are therefore represented by the characteristics of the predicate devices. The "reported device performance" is the specification of the proposed device, which is considered acceptable if it falls within a similar range or has slight differences that do not affect safety or effectiveness.
Below is a combined table summarizing the key performance parameters of the proposed device (Multifunctional Series) and its two primary predicate devices (Intense Pulsed Light (IPL) Systems (K122995) and IPULSELIGHT IPL SYSTEM (K093627)). The "Remark" column indicates if the characteristic is considered "Substantially Equivalent" (SE) or subject to "Analysis," which then details why the difference is deemed acceptable.
Table 1: Multifunctional Series Device Performance vs. Predicate Devices
| ITEM | Proposed Device (Multifunctional Series) | Predicate Device 1 (K122995) | Predicate Device 2 (K093627) | Acceptance Criteria (based on Predicate Range) | Reported Device Performance (Proposed Device) | Acceptance Met? (Based on document's analysis) |
|---|---|---|---|---|---|---|
| General Characteristics | ||||||
| Light Source | Intense pulsed light | Intense pulsed light | Intense pulsed light | Intense pulsed light | Intense pulsed light | Yes (SE) |
| Deliver system | Sapphire | Sapphire | Sapphire | Sapphire | Sapphire | Yes (SE) |
| Max. Power (W) | 2000 W (Aeslight-S3D, HONKON-S3C), 1250 W (HONKON-M40e+, HONKON-M80e+) | 2000 W | 1200 W | 1200 - 2000 W | 1250 W - 2000 W | Yes (Analysis 7) |
| Operating Parameters | ||||||
| Wavelength (nm) | 610-1200nm, 585-1200nm, 530-1200nm (depending on application) | 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) | Overlapping ranges with predicates (e.g., 530-1200nm, 585-1200nm, 610-1200nm) | Within or very close to predicate ranges | Yes (Analysis 1) |
| Energy Range (J/cm²) | 20-50 J/cm² | 10-60 J/cm² | 10-60 J/cm² | 10-60 J/cm² | 20-50 J/cm² | Yes (Analysis 2) |
| Pulse Delay (ms) | 0.1-40 ms | 5 - 50 ms | 5 - 50 ms | 5 - 50 ms | 0.1-40 ms | Yes (Analysis 3) |
| Pulse Duration (ms) | 1-25 ms | 1-20 ms | 2-20 ms | 1-20 ms (Predicate 1), 2-20 ms (Predicate 2) | 1-25 ms (Proposed device covers and slightly exceeds upper bound of predicates, but deemed acceptable) | Yes (Analysis 4) |
| 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) | Various similar sizes offered by predicates (e.g., 12x33mm, 15x50mm, 12x35mm, 15x45mm) | 8mm40mm, 15mm60mm | Yes (Analysis 5) |
| Specific IFU Settings | ||||||
| Hair Removal Wavelength | 610-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Overlapping/similar ranges. | 610-1200 | Yes (Analysis 6) |
| Hair Removal Energy | 20-50 | 10-44 | 10-46 | Overlapping/similar ranges. | 20-50 | Yes (Analysis 6) |
| Hair Removal Pulse Duration | 3-15 ms | 3-14 | 4-15 | Overlapping/similar ranges. | 3-15 ms | Yes (Analysis 6) |
| Hair Removal Pulse Delay | 15-35 | 16-32 | 15-30 | Overlapping/similar ranges. | 15-35 | Yes (Analysis 6) |
| Acne Wavelength | 530-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Overlapping/similar ranges. | 530-1200 | Yes (Analysis 6) |
| Acne Energy | 20-50 | 10-40 | 10-42 | Overlapping/similar ranges. | 20-50 | Yes (Analysis 6) |
| Acne Pulse Duration | 3-10 | 3-8 | 3-9 | Overlapping/similar ranges. | 3-10 | Yes (Analysis 6) |
| Vascular Lesions Wavelength | 585-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Overlapping/similar ranges. | 585-1200 | Yes (Analysis 6) |
| Vascular Lesions Energy | 20-50 | 10-42 | 10-44 | Overlapping/similar ranges. | 20-50 | Yes (Analysis 6) |
| Vascular Lesions Pulse Duration | 3-10 | 3-8 | 3-9 | Overlapping/similar ranges. | 3-10 | Yes (Analysis 6) |
2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) submission based on substantial equivalence, not a de novo clinical study for device performance validation. Therefore, there is no specific "test set sample size" as would be associated with a typical clinical trial evaluating a new device's performance. The study described is a "Bench Test" outlined in item 7: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
- Sample Size: Not applicable in the context of a clinical test set. The "samples" would be the device itself and its components tested against design specifications and international standards.
- Data Provenance: The bench tests were conducted by the manufacturer, Beijing Honkon Technologies Co., Ltd., which is based in Beijing, P.R. China. The data would be considered retrospective in the sense that it's a comparison to already approved predicate devices and adherence to established standards rather than data from a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since there was no clinical "test set" in the traditional sense as part of this 510(k) submission, no experts were explicitly used to establish ground truth for a test set. The "ground truth" for proving substantial equivalence lies in the established safety and effectiveness profiles of the legally marketed predicate devices and the international standards (IEC 60601-1, IEC 60601-1-2) that the proposed device complies with.
4. Adjudication Method for the Test Set
Not applicable. As noted above, there was no clinical test set requiring expert adjudication for establishing ground truth. The "adjudication" in a 510(k) process is the review by the FDA to determine if substantial equivalence has been demonstrated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices or those requiring human interpretation of results, and it's not a standard requirement for IPL devices seeking 510(k) clearance based on substantial equivalence to existing devices for aesthetic applications. Therefore, there is no reported effect size for how much human readers improve with AI vs without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is an Intense Pulsed Light system, a physical medical device, not a software algorithm. Therefore, "algorithm only" performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is established by:
- Predicate Device Equivalence: The safety and effectiveness established for the legally marketed predicate devices (K122995 and K093627). The proposed device is deemed substantially equivalent because its technological characteristics and intended use are highly similar, and any minor differences are argued not to affect safety or effectiveness.
- Compliance with International Standards: Adherence to recognized consensus standards for medical electrical equipment (IEC 60601-1 and IEC 60601-1-2). These standards provide a benchmark for fundamental safety and essential performance.
In essence, the "ground truth" is that the predicate devices are safe and effective, and the new device is sufficiently similar to share that "truth."
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The submission is for a physical IPL device based on established technology.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
{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: ____
-
- 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
-
- 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
- Submission Correspondent
{1}------------------------------------------------
S3 510(k) Summary
-
- Proposed Device Identification
Proposed Device Name: Multifunctional Series Proposed Device Common Name: Intense Pulse Light (IPL)
- Proposed Device Identification
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 settingandwavelengthscope | Skin type | ||||
|---|---|---|---|---|---|---|
| I | II | III | IV | V | ||
| HairRemoval | 610-1200 | 610-1200 | 610-1200 | 610-1200 | 610-1200 | |
| Acne | 530-1200 | 530-1200 | 530-1200 | 530-1200 | 530-1200 | |
| VascularLesions | 585-1200 | 585-1200 | 585-1200 | 585-1200 | 585-1200 |
-
- Predicate Device Identification
510(k) Number: K122995 Predicate Device Name: Intense Pulsed Light (IPL) Systems Manufacturer: Beijing KES Biology Technology Co., Ltd.
- Predicate Device Identification
510(k) Number: K093627 Predicate Device Name: IPULSELIGHT IPL SYSTEM Manufacturer: Shanghai APOLO Medical Technology Co., Ltd
-
- 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.
-
- 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 | |
| IntendedUse | The MultifunctionalSeries(inclusivedeviceofthehandpiece used to deliverpulsed-lightenergy)areindicated for use in surgical,aestheticandcosmeticapplications in hair removal.moderate inflammatory acnevulgaris.andbenigncutaneous vascular lesions. | آل المحافظ من المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافق المحافقIntense Pulsed Light (IPL) S(inclusiveystemsofthehandpiece used to deliverenergy )pulsed-lightareindicated for use in surgical,aesthericandcosmeticapplicationsinpermanenthair reduction, treatment ofpigmented lesions, moderateinflammatory acne vulgaris,ephelides(freckles),andvascular lesions. | IPulseLight IPL System (HS 300C,HS 650) are identical with regard toindications for use includingrecommended filters to be used withFitzpatrick skin type, Both modelsare intended for medical use in thetreatment of the followingdermatologic conditions:Permanent hair reduction- long-termstable reduction in number of hairsre-growing after a treatment regimentTreatment of:- Moderate inflammatory acnevulgaris- Benign pigmented epidermallesions including dy schromia,hyperpigmentation, melasma,ephelides (freckles).- Cutaneous lesions including scars- Benign cutaneous vascular lesionsincluding port wine stains,hemangiomas, facial, truncal and legtelangiectasias, erythema of rosacea,leg veins, spider anglomas andvenous malformations.The integrated thermal cooling isindicated for use in cooling theepidermis at the treatment site priorto, during, and after light treatmentin general aesthetic dermatologic andplastic surgery procedures· Reduce pain during lighttreatment (via partial anesthesia fromcooling)- Reduce discomfort during and/orassociated with light treatment- Minimize thermal injury,including thermal necrosis, tonon-larget skin and skin structuresduring and/or associated with lighttreatment, thus reducing possiblecomplications such as scabbing.scarring, hyper - and/or hypopigmentation- Allow the use of higher light orlaser fluencies for light treatments(such as for hair removal and thetreatment of vascular or pigmentedlesions)- Reduce potential side effects oflight treatments (such as for hairremoval and the treatment ofvascular or pigmented lesions) | ਟ ਦ | |
| ITEM | Proposed DeviceMultifunctional Series(Aeslight-S3D) | Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995) | Predicate DeviceIPULSELIGHT 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) | Analysis1 | |
| Deliver system | Sapphire | Sapphire | Sapphire | SE | |
| Energy Range | 20-50J/cm² | 10-60J/cm² | 10-60J/cm2 | Analysis2 | |
| Pulse Delay | 0.1-40ms | 5 - 50ms | 5 - 50ms | Analysis3 | |
| Pulse Duration | 1-25 ms | 1-20 ms | 2-20 ms | Analysis4 | |
| 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) | Analysis5 | |
| 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 | Analysis6 | |
| 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 | Analysis6 | |
| 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; 15mmX50mm15mmX35mm | 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 | Analysis6 |
| Pulse Delay(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm15mmX35mm | 12x25mm,12x35mm, 12x50mm,15x35mm, 15x45mm |
Table III-3 Performance Comparison of model HONKON-S3C
| 17EM | Proposed DeviceMultifunctional Series(HONKON-S3C) | Predicate DeviceIntense Pulsed Light (IPL)Systems(K 122995) | Predicate DeviceIPULSELIGHT 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 | Analysis2 |
| Pulse Delav | 0.1-40ms | 5 - 50ms | 5 - 50ms | Analysis3 |
| Pulse Duration | 1-25 ms | 1-20 ms | 2-20 ms | Analysis4 |
| 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, | Analysis5 |
| 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 | Analysis6 |
| 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 | Analysis6 |
| Pulse Delay(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm15mmX35mm | 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 | Analysis6 |
| Pulse Delay(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm15mmX35mm | 12x25mm,12x35mm, 12x50mm,15x35mm, 15x45mm | |
| ITEM | Proposed DeviceMultifunctional Series(HONKON-M40e+) | Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995) | Predicate DeviceIPULSELIGHT 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) | Analysis1 |
| Deliver system | Sapphire | Sapphire | Sapphire | SE |
| Energy Range | 20-50J/cm² | 10-60J/cm² | 10-60J/cm² | Analysis2 |
| Pulse Delay | 0.1-40ms | 5 - 50ms | 5 - 50ms | Analysis3 |
| Pulse Duration | 1-25 ms | 1-20 ms | 2-20 ms | Analysis4 |
| Max. Power | 1250 W | 2000 W | 1200 W | Analysis7 |
| 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) | Analysis5 |
| 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 | Analysis6 |
| 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 | Analysis6 |
| 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; 15mmX50mm15mmX35mm | 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 | Analysis6 |
| Pulse Delay(ms) | 15-35 | 16-32 | 15-30 | |
| Spot size | 8mm X 40mm; 15mm X 60mm | 12mm X33mm; 15mmX50mm15mmX35mm | 12x25mm,12x35mm,12x50mm,15x35mm, 15x45mm |
53-6
{6}------------------------------------------------
・
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 DeviceMultifunctional Series(HONKON-M80e+) | Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995) | Predicate DeviceIPULSELIGHT 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) | Analysis1 |
| Deliver system | Sapphire | Sapphire | Sapphire | SE |
| Energy Range | 20-50J/cm2 | 10-60J/cm2 | 10-60J/cm2 | Analysis2 |
| Pulse Delay | 0.1-40ms | 5 - 50ms | 5 - 50ms | Analysis3 |
| Pulse Duration | 1-25 ms | 1-20 ms | 2-20 ms | Analysis4 |
| Max. Power | 1250 W | 2000 W | 1200 W | Analysis7 |
| 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 | Analysis6 |
| 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 | Analysis6 |
| 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; 15mmX50mm15mmX35mm | 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 | Analysis6 |
| 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; 15mmX50mm15mmX35mm | 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 settingandwavelengthscope | Skin type | ||||
|---|---|---|---|---|---|---|
| I | II | III | IV | V | ||
| HairRemoval | 610-1200 | 610-1200 | 610-1200 | 610-1200 | 610-1200 | |
| Acne | 530-1200 | 530-1200 | 530-1200 | 530-1200 | 530-1200 | |
| VascularLesions | 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
Page 1 of 1
§ 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.