(53 days)
Not Found
No
The summary describes a standard IPL system based on selective photothermolysis and does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes.
The device is intended for medical use in the treatment of various dermatologic conditions, indicating a therapeutic purpose.
No
The device description indicates that it is an IPL treatment system used for therapeutic purposes (e.g., hair reduction, acne, lesion treatment) by selectively heating targets in the skin, not for diagnosing conditions.
No
The device description explicitly details hardware components such as a main unit, control panel, and treatment handpiece(s), and describes the physical mechanism of action involving intense pulsed light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states that this is an IPL treatment system that delivers light energy to the skin for therapeutic purposes (hair reduction, acne, lesions, vascular conditions). This is a direct treatment applied to the body, not a diagnostic test performed on a sample from the body.
- Intended Use: The intended uses listed are all related to treating dermatologic conditions directly on the skin.
- Device Description: The description focuses on the light source, filters, and how the energy interacts with the skin's chromophores. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IPL treatment system is 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;
- 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 angiomas and venous malformations.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The IPL Treatment Systems utilizes an intense, visible, broad-spectrum pulse of light that when used with interchangeable filters, allowing it to selectively heat the target for different indications. The optical component is intended to drive the IPL energy to concentrate where the optical energy has selectively heated the target.
The Intense pulsed light (IPL) is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. The light-based component delivers optical energy that is absorbed by specific chromophores in the skin, which is converted to heat, according to the principle of selective photothermolysis.
The proposed device consists of the main unit, control panel and the treatment handpiece(s).
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
Prescription Use
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)
Non-Clinical Testing:
A series of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
- Electrical safety and electromagnetic compatibility (IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012, IEC 60601-1-2:2014, IEC 60601-2-57: 2011)
- Biocompatibility Evaluation: The contact material of the proposed device is identical to that of the iPulseLight IPL System cleared in K093627. Tests performed: Cytotoxicity, Skin irritation, Skin Sensitization.
Clinical Testing:
It is not applicable.
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
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a caduceus, which is a traditional symbol of medicine. The text on the right is in blue and is arranged in three lines.
Shanghai Apolo Medical Technology Co., Ltd. Felix Li RA Supervisor 4F, Building A, No.388, Yindu Road, Xuhui District Shanghai, Shanghai 200231 China
Re: K200746
Trade/Device Name: IPL Treatment Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: ONF Dated: March 9, 2020 Received: March 23, 2020
Dear Felix Li:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200746
Device Name IPL Treatment System
Indications for Use (Describe)
The IPL treatment system is 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;
-
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 angiomas and venous malformations.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 3-510(k) summary
l Submitter
Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231, China
Establishment Registration Number: 3007120647
Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn
Date of preparation: Apr 28th, 2020
II Proposed Device
| Trade Name of Device: | IPL Treatment Systems |
|---|---|
| Common name: | Laser surgical instrument for use in general and plastic surgery |
| and in dermatology | |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product code: | ONF |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K093627 |
|---|---|
| Trade name: | iPulseLight IPL System (HS 300C, HS 650) |
| Common name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification: | Class II |
| Product Code: | ONF |
| Manufacturer | Shanghai APOLO Medical Technology Co., Ltd. |
IV Device description
The IPL Treatment Systems utilizes an intense, visible, broad-spectrum pulse of light that when used with interchangeable filters, allowing it to selectively heat the target
4
for different indications. The optical component is intended to drive the IPL energy to concentrate where the optical energy has selectively heated the target.
The Intense pulsed light (IPL) is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. The light-based component delivers optical energy that is absorbed by specific chromophores in the skin, which is converted to heat, according to the principle of selective photothermolysis.
The proposed device consists of the main unit, control panel and the treatment handpiece(s).
V Indication for use
The IPL treatment systems is 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;
- -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 leq telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.
| Item | Proposed device | Predicate device
(K093627) | Discussion |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Product
Code | ONF | ONF | Identical |
| Regulation
No. | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Class | Class II | Class II | Identical |
| Indication
for use | The IPL treatment
systems is intended for
medical use in the
treatment of the following
dermatologic conditions:
- Permanent hair
reduction- long-term | 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 | The
indications
of
the
proposed
device
covered by
the |
| | stable reduction in
number of hairs
re-growing after a
treatment regimen; | intended for medical use in
the treatment of the
following dermatologic
conditions: | predicate.
The cooling
system is
an integral
part of the
device. |
| - | Moderate
inflammatory acne
vulgaris; | Permanent hair
reduction- long-term
stable reduction in
number of hairs
re-growing after a
treatment regimen. | |
| - | Benign pigmented
epidermal lesions
including dyschromia,
hyperpigmentation,
melasma, ephelides
(freckles); | Treatment of: | |
| - | Cutaneous lesions
including scars; | • Moderate
inflammatory acne
vulgaris | |
| - | Benign cutaneous
vascular lesions
including port wine
stains, hemangiomas,
facial truncal and leg
telangiectasias,
erythema of rosacea,
leg veins, spider
angiomas and venous
malformations. | • 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 telangiectasia,
erythema of
rosacea, leg veins,
spider angiomas
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 of lesions) | |
| Light source | Intense pulsed light
(Xenon Flash Lamp) | Intense pulsed light (Xenon
Flash Lamp) | Identical |
| Wavelength | 420 – 1200 nm | 420 – 1200 nm | Identical |
| | | | |
| range | | | |
| Hanpiece ports | HS-650K&HS-660K: 2
HS620K, HS-300CK &
HS-310K: 1 | HS 650: 2
HS 300C: 1 | Identical |
| Structure | HS-650K&HS-660K:
Vertical
HS620K, HS-300CK &
HS-310K: Table top | HS 650: Vertical
HS 300C: Table top | Identical |
| Energy output | 4.1-50.8 J/cm² | 10-50 J/cm² | Equivalent |
| Pulse width | 5-20 ms | 2-20 ms | Equivalent |
| Pulse duration | 5-50 ms | 5-50 ms | Identical |
| Spot size | 1235mm, 1550mm | 1235mm, 1550mm | Identical |
| Filters | 420 -1200nm: Acne;
510 -1200nm: Acne,
vascular, pigment;
560 -1200nm: Acne,
vascular, pigment;
610-1200nm: Hair
removal;
640-1200nm: Hair
removal;
690-1200nm: Hair
removal; | 420 -1200nm: Acne;
510 -1200nm: Acne,
vascular, pigment;
560 -1200nm: Acne,
vascular, pigment;
610-1200nm: Hair removal;
640-1200nm: Hair removal;
690-1200nm: Hair removal; | Identical |
| Fluences | 420 -1200nm:
4.1-50.8J/cm²;
510 -1200nm: 3.8-47
J/cm²;
560 -1200nm: 3.7-43.3
J/cm²;
610-1200nm: 3.5-38.7
J/cm²;
640-1200nm:
3.3-37.4J/cm²;
690-1200nm:
3.1-33.4J/cm²; | 420 -1200nm: 10-50J/cm²;
510 -1200nm: 9.2-46.35
J/cm²;
560 -1200nm: 9-42.6 J/cm²;
610-1200nm: 8.5-38.1
J/cm²;
640-1200nm: 8-36.8J/cm²;
690-1200nm:
7.6-32.9J/cm²; | The
fluences for
each filter
are at
similar
energy
level,
considered
equivalent. |
| Output mode | Pulse mode | Pulse mode | Identical |
| Deliver
materials | Direct sapphire Coupling | Direct sapphire Coupling | Identical |
| Cooling
method | HS-650K&HS-660K:
Water cooling, forced-air
cooling, copper and TEC;
HS620K,
HS-300CK&HS-310K:
Water cooling and
forced-air cooling, | TEC and circulating water &
air | Equivalent |
VI Comparison of technological characteristics with the predicate devices
5
6
7
8
VII Non-Clinical Testing
A series of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility
- IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General ● requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-57: 2011 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Biocompatibility Evaluation:
The contact material of the proposed device is identical to that of the iPulseLight IPL System cleared in K093627.
Per FDA's Biocompatibility Guidance issued on June 16, 2016 and with regard to Table A.1 Evaluation Tests for consideration in ISO, "Use of international Standard ISO 10993-1, Biological evaluation of medical - Part 1: Evaluation and testing within a risk management process," the following tests performed on the material which contacts with human for Biocompatibility:
- Cytotoxicity;
- Skin irritation; ●
- Skin Sensitization .; ●
9
VIII Clinical Testing
It is not applicable.
IX Conclusion substantially equivalent to the predicate device.