(118 days)
Not Found
No
The summary describes a standard IPL device based on selective thermolysis and does not mention any AI/ML components or functionalities.
Yes
The device is indicated for medical treatments such as "treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions," which are therapeutic applications.
No
The provided text explicitly states the device is used for various aesthetic and cosmetic applications (e.g., hair reduction, treatment of lesions), not for diagnosing medical conditions. It works by delivering pulsed light for therapeutic effects, not for diagnosis.
No
The device description explicitly states it is an "Intense Pulsed Light (IPL) system" which delivers light at a specific wavelength range and operates on the principle of selective thermolysis, indicating it is a hardware device that emits light energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states surgical, aesthetic, and cosmetic applications for treating conditions like hair reduction, pigmented lesions, acne, freckles, and vascular lesions. These are all treatments applied directly to the patient's body.
- Device Description: The description explains how the device works by delivering pulsed light to target chromophores within the body. This is a therapeutic mechanism, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body, which is a defining characteristic of IVD devices. The device interacts directly with the patient's skin.
Therefore, this device falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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 reduction, treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions.
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.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense pulsed light
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 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.
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.
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
§ 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.
0
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
1
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
2
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 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. | 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 | ||
| 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-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 removal and the treatment of | ||
| vascular or pigmented lesions) - Reduce | ||
| potential side effects of light treatments | ||
| (such as for hair removal and the treatment |
8. Substantially Equivalent Comparison
Table II-1 SE Comparison
3
:
:
.
.
| 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. power | ||
| consumption | 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; 15mmX50mm | |
| 15mmX35mm | 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; 15mmX50mm | |
| 15mmX35mm | 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 |
:
4
| Pulse Delay (ms) | 16-32 | 15-30 |
|---|---|---|
| Spot Size (mm) | 12mm X33mm; 15mmX50mm | |
| 15mmX35mm | 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; 15mmX50mm | |
| 15mmX35mm | 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; 15mmX50mm | |
| 15mmX35mm | 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.
5
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
6
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
7
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