(157 days)
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with dual lamps that work together and can emit mutipulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It has skin-safe detection. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
The provided text is an FDA 510(k) clearance letter for an "Ice Cooling IPL Hair Removal Device." It describes the device, its intended use, and a comparison with predicate devices to establish substantial equivalence. However, this document does not contain, nor is it expected to contain, the detailed acceptance criteria and study results typically found in a clinical study report for device performance, especially for AI/ML-driven devices involving expert interpretation or comparative effectiveness studies.
The document focuses on:
- Substantial Equivalence: Demonstrating the new device is as safe and effective as legally marketed predicate devices.
- Performance Data (Non-Clinical): Summarizing tests for biocompatibility, electrical safety and EMC, eye safety, software verification and validation, and usability. These are largely engineering and safety tests rather than evaluations of device clinical effectiveness (e.g., hair removal efficacy).
Therefore, I cannot fulfill your request for acceptance criteria and study details related to "device performance" in the context of an AI/ML device (e.g., human reader improvement with AI assistance, standalone algorithm performance, ground truth establishment by experts, MRMC studies) because this information is not present in the provided FDA clearance letter.
The device described is an IPL (Intense Pulsed Light) hair removal device, which is a physical device that emits light to reduce hair growth. It does have software/firmware control, but it's not presented as an AI/ML-driven diagnostic or imaging interpretation device that would involve the kind of "acceptance criteria" you've outlined (e.g., related to sensitivity, specificity, or expert consensus on interpretations). The "performance data" here relates to the safety and fundamental operation of the physical device as required for a 510(k) submission.
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December 13, 2024
Shenzhen Ulike Smart Electronics Co., Ltd. Yang Blue Registration Director 810,Bldg 1,Xunmei Science & Technology Plaza,No. 8 Keyuan Rd Science Park Community, Yuehai Sub-District,Nanshan District Shenzhen, Guangdong 518000 China
Re: K241998
Trade/Device Name: Ice Cooling IPL Hair Removal Device (U120 DB, U120 RE, U120 GP, U120 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) 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: OHT Dated: July 6, 2024 Received: July 9, 2024
Dear Yang Blue:
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 (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 available 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.
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to. 21 CFR 820.30. Design controls: 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -> 21:37:46 -05'00' Tanisha Hithe 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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Indications for Use
510(k) Number (if known) K241998
Device Name
Ice Cooling IPL Hair Removal Device (UI20 DB, U20 RE, UI20 GP, UI20 PW, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 BR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S MP)
Indications for Use (Describe)
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of K241998
I. Submitter
Shenzhen Ulike Smart Electronics Co.,Ltd. Address:810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guangdong, P.R. China Contact person: Blue Yang Email: blue@ulike.com The date the summary was prepared: 12/9/2024
II. Device
Name of Device: Ice Cooling IPL Hair Removal Device
Model(s): UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP,
Common or Usual Name: Light Based Over-The-Counter Hair Removal
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: OHT
Regulation Number: 21 CFR 878.4810
| PredicateDevice | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 | PredicateDevice 4 | PredicateDevice 5 |
|---|---|---|---|---|---|
| 510(k) number | K230122 | K130315 | K230739 | K240016 | K242039 |
| Trade Name | IPL HairRemovalDevice | iPulse HairRemovalSystem | Hand-held IPLdevice (IPLHome UseHair RemovalDevice) | IPL HairRemovalDevice | Ice CoolingIPL HairRemovalDevice |
| Manufacturer | Shenzhen UlikeSmartElectronicsCo., Ltd. | CyDen Ltd | ShenzhenIONKAMedicalTechnologyCo., Ltd. | ShenzhenJianrongBiomedicalElectronicsCo., Ltd | Shenzhen Ulike SmartElectronicsCo., Ltd. |
III. Predicate Device
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IV. Device Description
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with dual lamps that work together and can emit mutipulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It has skin-safe detection. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
Ice Cooling IPL Hair Removal Device includes the following models: UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S MP, UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP. Their intended use, performance and operation are basically identical. The model differences are enclosure color, a detachable accessory cover, and skin tone recognition (only for UI20S series with an accessory cover and with skin tone recognition). (U120 series: UI20 WH, U120 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20 WG; UI20S series: UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S WH, UI20S GR, UI20S BS, UI20S MP, UI20S DB, UI20S RE, UI20S PW, UI20S GP).
V. Indications for Use
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
VI. Comparison of Technological Characteristics With the Predicate
Devices
The Ice Cooling IPL Hair Removal Device has the same intended use and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices.
Ice Cooling IPL Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, specifications and performance:
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| Comparison Items | Subject Device | PredicateDevice 1 | Predicate Device2 | Predicate Device3 | Predicate Device4 | Predicate Device5 | Remark | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 510(k) number | / | K230122 | K130315 | K230739 | K240016 | K242039 | / | |||||||||
| Trade Name | Ice CoolingIPL HairRemovalDevice | IPL HairRemovalDevice | iPulse HairRemoval System | Hand-helddevice (IPLHome Use HairRemoval Device) | IPL HairRemovalDevice | Ice Cooling IPLHair RemovalDevice | / | |||||||||
| Manufacturer | ShenzhenUlike SmartElectronicsCo., Ltd. | Shenzhen UlikeSmartElectronicsCo., Ltd. | CyDen Ltd | Shenzhen IONKAMedicalTechnology Co.,Ltd. | ShenzhenJianrongBiomedicalElectronicsCo., Ltd | Shenzhen UlikeSmartElectronics Co.,Ltd. | / | |||||||||
| Regulationnumber | 21 CFR878.4810 | 21 CFR878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR878.4810 | 21 CFR878.4810 | Same | |||||||||
| Product code | OHT | OHT | OHT | OHT | OHT | OHT | Same | |||||||||
| Deviceclassification | Class II | Class II | Class II | Class II | Class II | Class II | Same | |||||||||
| Indication for use/Intended use | Ice CoolingIPL HairRemovalDevice withsapphiretreatmentwindow isindicated for | IPL HairRemovalDevice isindicated forthe removal ofunwanted hair.The device isalso indicated | The iPulse HairRemoval SystemisanOver-the-counterdevice intendedfor the removal ofunwanted hair. | IPL Home UseHair RemovalDevice isindicated for theremoval ofunwanted hair.The device is alsoindicated for the | IPL HairRemovalDevice isindicated forthe removal ofunwanted hair.The device isalso indicated | Ice Cooling IPLHair RemovalDevice withsapphiretreatmentwindow isindicated for theremoval of | Same | |||||||||
| the removal ofunwanted hair.The device isalso indicatedfor thepermanentreduction inhair regrowth,defined as thelong-term,stablereduction in thenumber ofhairs regrowingwhen measuredat 6, 9 and 12months afterthe completionof a treatmentregime. | forthepermanentreduction inhair regrowth,defined as thelong-term,stable reductionin the numberofhairsregrowingwhen measuredat 6, 9 and 12months afterthe completionof a treatmentregime. | OTC | for thepermanentreduction in hairregrowth, definedas the long-term,stable reductionin the number ofhairs regrowingwhen measured at6, 9 and 12months after thecompletion of atreatment regime. | OTC | unwanted hair.The device isalso indicated forthe permanentreduction in hairregrowth,defined as thelong-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9and 12 monthsafter thecompletion of atreatmentregime. | Same | ||||||||||
| Prescription or OTC | OTC | OTC | OTC | OTC | OTC | Same | ||||||||||
| Applicable skin | FitzpatrickSkin Types I-V | FitzpatrickSkin Types I-V | unknown | Fitzpatrick SkinTypes I-V | unknown | Fitzpatrick SkinTypes I-V | Same | |||||||||
| Treatment area | Large areas | Large areas | leg, arm, bikini | unknown | unknown | Large areas (e.g. | Same | |||||||||
| (e.g. arms,legs, chest) andsmall areas(e.g. lip) | (e.g. arms, legs,chest) andsmall areas(e.g. lip) | and underarm | arms, legs, chest)and small areas(e.g. lip) | |||||||||||||
| Device design | ||||||||||||||||
| Source energy | Supplied byexternaladapter | Supplied byexternaladapter | Supplied byexternaladapter | Supplied byexternaladapter | Supplied byexternaladapter | Supplied byexternaladapter | Same | |||||||||
| Power supply | 100-240V~,50/60Hz | 100-240V~,50/60Hz | 100-240V~,50/60Hz | 100-240V~,50/60Hz | 100-240V~,50/60Hz | 100-240V~,50/60Hz | Same | |||||||||
| Dimension | 206.73mm68.68mm54.29mm | 60mm x 38mmx170mm | unknown | FZ-608,FZ-608G:9814760(mm)FZ-100:1987144(mm)FZ-200:2166852(mm) | unknown | 206.73mm68.68 mm54.29mm | SENote 1 | |||||||||
| Sterilization | Not required | Not required | Not required | Not required | Not required | Not required | Same | |||||||||
| Output specification | ||||||||||||||||
| Light source | Intense PulsedLight | Intense PulsedLight | Intense PulsedLight | Intense PulsedLight | Intense PulsedLight | Intense PulsedLight | Same | |||||||||
| Energy medium | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Same | |||||||||
| Wavelength range | 550-1200mm | 560-1200nm | 530-1100nm | 510nm~1200nm | 550-1200nm | 550-1200nm | SENote 2 | |||||||||
| Energy density | $1.67~6.67J/cm^2$ | $2.4-7.2J/cm^2$ | $7-10J/cm^2$ | $1.2-4.3J/cm^2$ | $2.79~6.41J/cm^2$ | SENote 3 | ||||||||||
| FZ-608,FZ-608G: 3.33 J/cm2FZ-100: 4.5 J/cm2FZ-200: 5.43 J/cm2 | ||||||||||||||||
| Output energy | $6.5~26J$ | $9.9~19.8J$ | $21~30J$ | $5.4~19.35J$ | $10.9J~25J$ | SENote 4 | ||||||||||
| FZ-608,FZ-608G: Level 1: 4.16J Level 2: 4.36J Level 3: 5.1J Level 4: 6.1J Level 5: 6.96J Level 6: 7.96J Level 7: 8.63J Level 8: 9.13J Level 9: 10.0J | ||||||||||||||||
| Spot size | $3.9cm^2$ | $3.3cm^2$ | $3cm^2$ | $4.5cm^2$ | $3.9cm^2$ | SENote 5 | ||||||||||
| Pulse duration | $0.88~3.20ms$Multipulse | $1.15-6.2ms$ | Variable -Single pulse 25milliseconds.to Double Pulse 20ms on, 60 ms off | $0.5~0.8 ms$ | unknown | $0.93ms~3.50ms$Single pulseDouble pulseTriple pulse | ||||||||||
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Same | |||||||||
| Delivery device | Directillumination totissue | Directillumination totissue | Directillumination totissue | Directillumination totissue | Directillumination totissue | Directillumination totissue | Same | |||||||||
| Output intensitylevel | 1-10 Levels | 5 Levels | unknown | FZ-608,FZ-608G: 9 levelsFZ-100: 9 levelsFZ-200: 6 levels | unknown | 1-10 Levels | SENote 7 | |||||||||
| Software/Firmware/Microprocess orControl? | Yes | Yes | Yes | Yes | Yes | Yes | Same | |||||||||
| Additional features | ||||||||||||||||
| Electrical safety | IEC 60601-1IEC 60601-1-2IEC60601-1-11IEC60601-2-57IEC60601-2-83 | ANSI AAMIES 60601-1IEC 60601-1-2IEC60601-1-11IEC60601-2-57IEC60601-2-83 | unknown | ANSI AAMIES60601-1 IEC60601-1-2 IEC60601-1-11 IEC60601-2-83 | IEC60601-2-83 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83 | Same | |||||||||
| Eye safety | IEC 62471 | IEC 62471 | unknown | IEC 60601-2-57 | IEC 62471 | IEC 62471 | Same | |||||||||
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10 | unknown | ISO 10993-5ISO 10993-10 | unknown | ISO 10993-5ISO 10993-10ISO 10993-23 | Same |
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Shenzhen Ulike Smart Electronics Co., Ltd.
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Shenzhen Ulike Smart Electronics Co., Ltd.
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Note 1:
The dimension belongs to basic characteristics. Although there is the dimension difference between subject device and the predicate devices, but it will not affect the function and intended use of the device, and they all comply with IEC 60601-1 requirements, so the difference will not raise safety and effectiveness issue.
Note 2:
Although there is a minor difference of the wavelength between the subject device and predicate devices, it is within the wavelength value of the predicate devices, so this difference will not raise any safety or effectiveness issue.
Note 3:
Although there is a minor difference of the energy density between the subject device and predicate devices, but the maximum energy density of subject device is within the range of the value of the predicate devices, and they all comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirements, so such minor difference would not raise safety or effectiveness issue.
Note 4:
Although there is a minor difference of the output energy between the subject device and predicate devices, but the maximum energy density of subject device is within the range of the value of the predicate devices, and they all comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirements, so such minor difference would not raise safety or effectiveness issue.
Note 5:
There is minor difference in spot size between the subject device and the predicate devices. The spot size is related to energy density and since the difference in energy density is not significant as explained in note 3, so this difference will not raise any safety or effectiveness issue.
Note 6:
Although there is a minor difference of the pulse width between the subject device and predicate devices, it is within the pulse width value of the predicate devices. In addition, the subject device comply with IEC 60601-2-83 and IEC 62471 requirement, so this difference will not raise any safety or effectiveness issue.
Regarding the multipulse, the subject device operated on multipulse while the predicate device 2 also operated on multipulse.
Regarding the multiple pulses at irregular pulse durations, the subject device operated on multipulse at irregular pulse durations while the predicate device 5 also operated on multipulse at irregular pulse durations.
Moreover, Temperature Test Report and Usability evaluation has been conducted to verify the users can use the device with multiple pulses safely and effectively, so such difference
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Shenzhen Ulike Smart Electronics Co., Ltd.
would not raise safety or effectiveness issue.
Note 7:
Though the subject device has 1-10 energy levels, which is different from the predicate device, this difference is insignificant and do not raise any safety or effectiveness problems.
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination.
Summarv of performance testing
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993- 1, 'Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process, Document", as recognized by FDA. The following testing was performed to, and passed, including:
ISO 10993-10:2021, Biological evaluation of medical devices Part 10: Tests for skin sensitization
ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for irritation
ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
IEC 60601- 1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11:2015+A1:2020 Medical Electrical Equipment=Part 1-11: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
IEC 60601-2-57:2011 Medical electrical equipment- Part 2-57: Particular
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requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use > IEC 60601-2-83:2019 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
3) Eye Safety
IEC 62471:2006 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software documentation consistent with Basic Documentation Level was submitted in this 510(k). System testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
5) Usability
The product usability has been evaluated and verified according to the following standard and FDA guidance
IEC 60601-1-6:2005+2012+2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Conclusion: Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Ice Cooling IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate devices.
§ 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.