(118 days)
The Intense Pulsed Light (IPL) Systems (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions.
The Intense Pulsed Light (IPL) Systems are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 430nm-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 penetration without using excessive energy levels and enables targeting of specific chromophores.
The provided text describes a 510(k) submission for the Intense Pulsed Light (IPL) Systems (K122995), which seeks to demonstrate substantial equivalence to a predicate device (IPULSELIGHT IPL SYSTEM, K093627). However, it does not contain information about a clinical study demonstrating the device's performance against specific acceptance criteria.
The document focuses on non-clinical bench tests to verify that the proposed device met design specifications and standard compliance, and a detailed comparison with the predicate device to establish substantial equivalence.
Therefore, many of the requested sections regarding acceptance criteria, study details, human reader performance, and ground truth establishment cannot be fulfilled from the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no specific performance acceptance criteria reported for clinical efficacy. The "acceptance criteria" discussed are primarily related to safety and technical specifications, which are implicitly met by complying with the listed standards and demonstrating similarity to the predicate device.
Safety and Technical Performance Criteria (Inferred from compliance and comparison):
| Acceptance Criteria Category | Reported Device Performance (Compliance/Similarity) |
|---|---|
| Electrical Safety | Complies with IEC 60601-1 |
| EMC (Electromagnetic Compatibility) | Complies with IEC 60601-1-2 |
| Biocompatibility - Cytotoxicity | Complies with ISO 10993-5 |
| Biocompatibility - Irritation & Skin Sensitization | Complies with ISO 10993-10 |
| Intended Use | Analogous to predicate device for permanent hair reduction, pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions. |
| Light Source | Intense pulsed light (Same as predicate) |
| Wavelength Range | 430-1200nm, 530-1200nm, 640-1200nm (Proposed device has similar ranges, with some optional variations compared to predicate) |
| Delivery System | Sapphire (Same as predicate) |
| Energy Density | 10-60J/cm² (Same as predicate) |
| Pulse Sequence | 1-15 pulses (Same as predicate) |
| Pulse Delay | 5-50ms (Same as predicate) |
| Pulse Width | 1-20ms (Similar to predicate's 2-20ms) |
| Spot Size | MED-210: 15mmX50mm, MED-230: 12mmX33mm, 15mmX50mm (Similar, with some variations, to predicate's various sizes) |
| Power Supply | 220V±20V 50Hz or 110V±20V 60Hz (Similar to predicate's 100/110V, 50 |
| Max. Power Consumption | MED-210: 1400 W, MED-230: 2000 W (Higher than predicate's 1200 W, but considered not to affect safety/effectiveness) |
| Therapeutic Parameters (e.g., Energy Range for indications) | Similar ranges for permanent hair reduction, pigmented lesions, acne vulgaris, ephelides, and vascular lesions compared to predicate. Differences are discussed and concluded not to affect effectiveness/safety. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The document states "Bench tests were conducted to verify that the proposed device met all design specifications," and these appear to be primarily engineering and safety compliance tests, not clinical performance studies involving a "test set" of patients or data in the typical sense of AI/diagnostic device evaluation. No information on data provenance or study type (retrospective/prospective) is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided. No clinical ground truth establishment is mentioned, as there is no clinical performance study described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This is relevant for studies involving human assessment of data, which is not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an IPL system for various cosmetic and therapeutic applications, not an AI-assisted diagnostic or interpretation tool. The submission is for a medical device that directly performs a treatment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical IPL system, not an algorithm, and its performance is inherently human-in-the-loop (operated by a practitioner).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For a treatment device, "ground truth" would typically refer to clinical outcomes measured against a recognized standard of care or objective physiological changes. No such clinical performance data or ground truth validation is detailed in this 510(k) summary, as the submission relies on substantial equivalence to the predicate device and compliance with safety standards rather than a de novo clinical efficacy study.
8. The sample size for the training set
Not applicable/Not provided. As there is no AI algorithm being developed or evaluated, there is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable/Not provided. See point 8.
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JAN 2 2 2013
Attachment II 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: K122995
- l. Date of Submission: September 17, 2012
-
- Sponsor
Beijing KES Biology Technology Co., Ltd. Building E, No.28 Langfa Yifa Industrial Park, Daxing District, Beijing, 102613, China
Contact Person: Mr. Xun Zeng Position: Vice President Tel: +86-10-84405668 Fax: +86-10-84404920 Email: info@keslaser.com
- Submission Correspondent 3. Ms. Diana Hong & Mr. 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
- Proposed Device Identification 4.
Proposed Device Name: Intense Pulsed Light (IPL) Systems Proposed Device Model: MED-210, MED-230 -
Classification: Class II Product Code: ONF Regulation Number: 21 CFR 878.4810 Review Panel: General and Plastic Surgery
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Intended Use Statement:
The Intense Pulsed Light (IPL) Systems (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions.
| Skin Types | ||||||
|---|---|---|---|---|---|---|
| Conditions | I | II | III | IV | V | |
| Hair | Filter setting and wavelength rang | 640-1200 | 640-1200 | 640-1200 | 690-1200 | 750-1200 |
| Pigmented lesions | 480-1200 | 530-1200 | 530-1200 | 560-1200 | 560-1200 | |
| Acne vulgaris | 430-1200 | 430-1200 | 430-1200 | 480-1200 | 530-1200 | |
| Ephelides | 480-1200 | 480-1200 | 530-1200 | 530-1200 | 530-1200 | |
| Vascular lesions | 530-1200 | 530-1200 | 560-1200 | 560-1200 | 590-1200 |
5. Predicate Device Identification
510(k) Number: K093627
Product Name: IPULSELIGHT IPL SYSTEM
Manufacturer: Shanghai APOLO Medical Technology Co., Ltd
- Device Description 6.
The Intense Pulsed Light (IPL) Systems are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 430nm-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 penetration without using excessive energy levels and enables targeting of specific chromophores.
Based on this, the IPL Systems (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, acsthetic and cosmetic applications in permanent hair reduction, treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions.
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was
- Non-Clinical Test Conclusion
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Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A 1EC 60601-1: 1988 +A1:1991+A2:1995, Medical Electrical Equipment - Part 1: General requirements for safety.
- A IEC 60601-1-2: 2007, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility -Requirements and tests.
- A ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
- ン ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
| Table II-1 SE Comparison | ||
|---|---|---|
| ITEM | Proposed Device | Predicate Device |
| Intense Pulsed Light (IPL) Systems | IPULSELIGHT IPL SYSTEM (K093627) | |
| Product Code | ONF | ONF |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | II | II |
| Intended Use | TheIntense Pulsed Light (IPL) Systems (inclusive ofthe handpiece used to deliver pulsed-light energy) areindicated for use in surgical, aesthetic and cosmeticapplications in permanent hair reduction, treatment ofpigmented lesions, moderate inflammatory acnevulgaris, ephelides (freckles), and vascular lesions. | IPulseLight IPL System (HS 300C, HS 650)are identical with regard to indications foruse including recommended filters to beused with Fitzpatrick skin type. Both modelsare intended for medical use in the treatmentof the following dermatologic conditions:Permanent hair reduction- long-term stablereduction in number of hairs re-growingafter a treatment regimen. Treatment of: -Moderate inflammatory acne vulgaris -Benign pigmented epidermal lesionsincluding dyschromia, hyperpigmentation,melasma, ephelides (freckles). - Cutaneouslesions including scars - Benign cutaneousvascular lesions including port wine stains,hemangiomas, facial, truncal and legtelangiectasias, erythema of rosacea, legveins, spider anglomas and venousmalformations. The integrated thermalcooling is indicated for use in cooling theepidermis at the treatment site prior to,during, and after light treatment in generalaesthetic dermatologic and plastic surgeryprocedures. - Reduce pain during lighttreatment (via partial anesthesia fromcooling) - Reduce discomfort during and/orassociated with light treatment - Minimizethermal injury, including thermal necrosis, tonon-target skin and skin structures duringand/or associated with light treatment, thusreducing possible complications such asscabbing, scarring, hyper - and/or hypopigmentation - Allow the use of higher lightor laser fluencies for light treatments (suchas for hair removal and the treatment ofvascular or pigmented lesions) - Reducepotential side effects of light treatments(such as for hair removal and the treatment |
8. Substantially Equivalent Comparison
Table II-1 SE Comparison
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:
:
.
.
| of vascular or pigmented lesions) | ||
|---|---|---|
| Light source | Intense pulsed light | Intense pulsed light |
| Wavelength | 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) |
| Deliver system | Sapphire | Sapphire |
| Energy density | 10-60J/cm² | 10-60J/cm² |
| Pulse sequence | 1~15 pulses | 1~15 pulses |
| Pulse delay | 5 - 50ms | 5 - 50ms |
| Pulse width | 1-20ms | 2-20ms |
| Spot size | MED-210: 15mmX50mm (optional: 12mmX33mm,15mmX35mm )MED-230: A: 12mm X33mm; B: 15mmX50mm(optional: 15mmX35mm) | 12x35mm, 15x50mm (Standard); 12x12mm,12x25mm, 12x50mm, 15x35mm, 15x45mm(Options) |
| Power Supply | 220V±20V 50Hz or 110V±20V 60Hz | 100/110V, 50 |
| Max. powerconsumption | MED-210: 1400 W MED-230: 2000 W | 1200 W |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
Table II-2 Setting Comparison of Specified Indication for Use
| ITEM | Proposed Device | Predicate Device |
|---|---|---|
| Intense Pulsed Light (IPL) Systems | IPULSELIGHT IPL SYSTEM (K093627) | |
| (MED-210, MED-230) | (HS 300C, HS 650) | |
| permanent hair reduction | ||
| Wavelength Range (nm) | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 |
| Energy Range (J/cm2) | 10-44 | 10-46 |
| Pulse Duration (ms) | 3-14 | 4-15 |
| Pulse Delay (ms) | 16-32 | 15-30 |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm15mmX35mm | 12x25mm,12x35mm,12x50mm,15x35mm,15x45mm |
| pigmented lesions | ||
| Wavelength Range (nm) | 480-1200/530-1200/560-1200 | 510-1200/560-1200 |
| Energy Range (J/cm2) | 12-44 | 14-46 |
| Pulse Duration (ms) | 3-9 | 2-9 |
| Pulse Delay (ms) | 16-32 | 15-30 |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm15mmX35mm | 12x25mm,12x35mm,12x50mm,15x35mm,15x45mm |
| moderate inflammatory acne vulgaris | ||
| Wavelength Range (nm) | 430-1200/480-1200/530-1200 | 420-1200/510-1200/560-1200 |
| Energy Range (J/cm2) | 10-40 | 10-42 |
| Pulse Duration (ms) | 3-8 | 3-9 |
:
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| Pulse Delay (ms) | 16-32 | 15-30 |
|---|---|---|
| Spot Size (mm) | 12mm X33mm; 15mmX50mm15mmX35mm | 12x25mm, 12x35mm, 12x50mm, 15x35mm,15x45mm |
| ephelides (freckles) | ||
| Wavelength Range (nm) | 480-1200/530-1200 | 510-1200 |
| Energy Range (J/cm2) | 10-42 | 12-44 |
| Pulse Duration (ms) | 3-8 | 3-9 |
| Pulse Delay (ms) | 16-32 | 15-30 |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm15mmX35mm | 12x25mm, 12x35mm, 12x50mm, 15x35mm,15x45mm |
| vascular lesions | ||
| Wavelength Range (nm) | 530-1200/560-1200/590-1200 | 510-1200/560-1200 |
| Energy Range (J/cm2) | 10-42 | 10-44 |
| Pulse Duration (ms) | 3-8 | 3-9 |
| Pulse Delay (ms) | 16-32 | 15-30 |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm15mmX35mm | 12x25mm, 12x35mm, 12x50mm, 15x35mm,15x45mm |
Difference in intended use, wavelength, spot size, power supply, Max. power consumption and setting of specified indication for use between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, Intense Pulsed Light (IPL) Systems, are determined to be Substantially Equivalent (SE) to the predicate device, IPULSELIGHT IPL SYSTEM (K093627), in respect of safety and effectiveness.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
January 22, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Beijing Kes Biology Technology Company, Limited % Mid-Link Consulting Company, Limited Ms. Diana Hong Correspondent, General Manager P.O. Box 237-023 Shanghai, China 200237
Re: K122995
Trade/Device Name: Intense Pulsed Light (IPL) Systems 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: December 26, 2012 Received: December 31, 2012
Dear Ms. Hong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Diana Hong
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section II Indications for Use
510(k) Number:
Device Name: Intense Pulsed Light (IPL) Systems
Indications for Use:
The Intense Pulsed Light (IPL) Systems (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair removal, skin rejuvenation, reduction of pigmented lesions, acne therapy, freckle, vascular lesions and facial blemish removal.
ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)
OVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Neil R Ogden 2013.01.18 08:52:24 -05'00'
(Division Sign-Off)
Division of Surgical Devices
510(k) Number K 122995
§ 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.