← Product Code [OHT](/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT) · K223618 # IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD (K223618) _Shenzhen Ulike Smart Electronics Co., Ltd. · OHT · Feb 28, 2023 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT/K223618 ## Device Facts - **Applicant:** Shenzhen Ulike Smart Electronics Co., Ltd. - **Product Code:** [OHT](/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT.md) - **Decision Date:** Feb 28, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use IPL Hair Removal Device 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. ## Device Story Over-the-counter, home-use IPL device for hair reduction; utilizes Xenon arc flashlamp to emit light pulses; sapphire treatment window (3.3cm2 spot size); powered by external adapter; finger-switch activation. Includes skin contact sensor to prevent pulse emission unless in full contact; integrated cooling function for user comfort. User operates device by placing treatment window against skin; light pulses target hair follicles below skin surface to reduce growth. No cutting or pulling involved. Output intensity levels adjustable (3 levels). Benefits include minimal pain and long-term hair regrowth reduction. ## Clinical Evidence Bench testing only. No clinical data provided. Evidence includes biocompatibility (ISO 10993-5, 10993-10), electrical safety/EMC (ANSI/AAMI ES60601-1, IEC 60601-1-2, 1-11, 2-57, 2-83), photobiological eye safety (IEC 62471), and usability engineering (IEC 60601-1-6). ## Technological Characteristics Xenon arc flashlamp IPL source; 560-1200nm wavelength; 3-6 J/cm² energy density; 3.3cm² spot size; 1-7ms pulse duration. Materials: ABS, PC, crystal (sapphire) window. Powered by external adapter (100-240V, 50/60Hz). Features skin contact sensor and cooling system. Software-controlled; moderate level of concern. Sterilization not required. ## Regulatory 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. ## Predicate Devices - iPulse SmoothSkin Gold Hair Removal System ([K160968](/device/K160968.md)) - IPL Hair Removal Device Joy Version, CB-027 ([K173813](/device/K173813.md)) ## Reference Devices - IPL HAIR REMOVAL SG-8025 ([K212318](/device/K212318.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text. February 28, 2023 Shenzhen Ulike Smart Electronics Co.,Ltd % Riley Chen Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, 518052 China Re: K223618 Trade/Device Name: IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD 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: December 2, 2022 Received: December 5, 2022 Dear Riley Chen: 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. {1}------------------------------------------------ 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 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 K. Chen -S for Jianting Wang 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223618 Device Name IPL Hair Removal Device Model(s): UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD #### Indications for Use (Describe) IPL Hair Removal Device 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary #### "510(k) Summary" as required by 21 CFR Part 807.92. #### I. Submitter Shenzhen Ulike Smart Electronics Co.,Ltd. No.8, Keyuan Road, Yuehai Sub-district, Nanshan District, Shenzhen, Guangdong, China Post code: 518000 Tel.: +86 18600825411 Shane Xie Registration Director Tel: +86 18600825411 Email: Shane@ulikebeauty.com #### II. Device Name of Device: IPL Hair Removal Device Model(s): U106 PL, U106 PN, U106 JL, U106 BR, U106 DB, U106 PR, U106 OG, U106 RD 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 #### III. Predicate Device Primary predicate device: | Manufacturer | Predicate Device | 510(k) Number | Approval Date | |----------------|--------------------------------------------------|---------------|---------------| | CyDen Limited. | iPulse SmoothSkin
Gold
Hair Removal System | K160968 | Apr.14, 2016 | Predicate device: | Manufacturer | Predicate Device | 510(k) Number | Approval Date | |---------------------------------|------------------------------------------------|---------------|----------------| | Shen Zhen CosBeauty Co.,
Ltd | IPL Hair Removal Device
Joy Version, CB-027 | K173813 | Sept. 07, 2018 | Reference device: | Manufacturer | Reference Device | 510(k) Number | Approval Date | |------------------------------------------------------------|------------------------------|---------------|---------------| | Dongguan Define Beauty
Electronic Technology Co.
Ltd | IPL HAIR REMOVAL SG-
8025 | K212318 | Jan. 14, 2022 | {4}------------------------------------------------ # IV. Device Description IPL Hair Removal Device (Model: UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD), is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable sapphire treatment window and the spot size is 3.3cm2 that is suitable for multiple hair removal areas. 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 cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience. IPL Hair Removal Device, model: UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI06 PL is Purple, UI06 PN is Pink, UI06 JL is Yellow, UI06 BR is Brown, UI06 DB is Dark Brown, UI06 PR is Dark Purple, UI06 OG is Maple Red, UI06 RD is Red). # V. Indications for Use IPL Hair Removal Device 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. Materials | Component
name | Material of Component | Body Contact Category | Contact Duration | |-------------------------------------------------------------------|---------------------------------|-------------------------------------------|--------------------| | IPL Hair Removal
Device (Enclosure
and treatment
window) | ABS, PC,
Crystal application | Surface-contacting
device: Intact skin | Less than 24 hours | We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion". # VII.Comparison of Technological Characteristics With the Predicate Device The IPL Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate devices and reference device. Any minor differences between the subject device and the listed predicate devices and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the {5}------------------------------------------------ predicate devices and reference device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices and reference device. IPL Hair Removal Device is compared with the following Predicate Devices and Reference Device in terms of intended use, design, specifications and performance: | Comparison
Elements | Subject Device | Primary Predicate
Device | Predicate Device | Reference Device | Remark | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | 510(k)
Number | K223618 | K160968 | K173813 | K212318 | / | | Trade name | IPL Hair Removal
Device | iPulse
SmoothSkin Gold Hair Removal
System | IPL Hair Removal
Device Joy Version, CB-
027 | IPL HAIR
REMOVAL SG-
8025 | / | | Manufacturer | Shenzhen Ulike
Smart Electronics
Co.,Ltd. | Cyden Limited. | Shen Zhen CosBeauty
Co., Ltd | Dongguan Define
Beauty Electronic
Technology Co.
Ltd | / | | Regulation
number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | Product code | OHT | OHT, GEX | OHT | OHT | Same | | Device
classification | Class II | Class II | Class II | Class II | Same | | Indication for
use/ Intended
use | IPL Hair Removal
Device 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. | The
iPulse
SmoothSkin Gold
Hair Removal System
is indicated for the
removal of unwanted
hair. The iPulse
Smoothskin Gold 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. | The IPL Hair Removal
Device Joy Version 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. The
device is used for adults
with Fitzpatrick skin
types I - IV. | The IPL Hair
Removal (Model:
SG-8025) is an
over the Counter
device intended for
the removal of
unwanted body
and/or facial hair
in adults. It is also
intended for
permanent
reduction in
unwanted hair.
Permanent hair
reduction is
defined as the
long-term stable
reduction in the
number of hairs re-
growing when
measured at 6. 9.
and 12 months
after the
completion of a | Same, in only
wording hair
difference | | Comparison
Elements | Subject Device | Primary
Device | Predicate Device | Reference Device | Remark | | | | | | treatment regimen. | | | Prescription
or OTC | OTC | OTC | OTC | OTC | Same | | Applicable
skin | Fitzpatrick Skin
Types I-V | Unknown | Fitzpatrick skin types I - IV | Unknown | Different | | Treatment
area | large areas (e.g. arms,
legs, chest) and small
areas (e.g. lip) | Unknown | Large areas (legs, arms,
back and abdomen), face
(upper lip, chin and
sideburns) | Body and face | Similar | | Device design | | | | | | | Source
energy | Supplied by external
adapter | External Power
supply | Supplied by external
adapter | Supplied by
external adapter | Same | | Power supply | 100~240V, 50/60Hz | 110V or 230V,
50/60Hz | 100-240 VAC, 50/60Hz | Unknown | Same | | Dimension | 58×34×179mm
(W x H x D) | Unknown | 126*78*200mm | 205*76*56mm
(H*W*D) | Different | | Sterilization | Not required | Not required | Not required | Not required | Same | | Output specification | | | | | | | Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed
Light | Same | | Energy
medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon lamp | Same | | Wavelength
range | 560-1200mm | 510-1100nm | 510-1200nm | 530nm | Similar | | Energy
density | 3~6 J/cm² | 3-6J/cm² | 1.8~5.1J/cm² | 2.5J/cm² Max | Similar | | Output
energy | 9.9~19.8J | 9~18J | Body lamp
cartridge | Level 1: 7.5J
Level 2: 8.5J
Level 3: 9.5J
Level 4: 11J
Level 5: 12J | Similar | | | | | 11.77~22.21J
510-1200nm | | | | | | | Facial lamp
cartridge
3.65~7.04J
512-1197nm
Bikini lamp
cartridge
3.84~7.22J
511-1200nm | | | | Spot size | 3.3cm² | 3cm² (3cm by 1cm) | Body: 4.2cm²
Bikini and face: 2.0cm² | 3.0cm² | Similar | | Pulse
duration | 1ms~7ms | 2ms to 10ms | 9.2~11.2ms | 1ms | Similar | | Pulsing
control | Finger switch | Finger switch | Finger switch | Finger switch | Same | | Comparison
Elements | Subject Device | Primary Predicate
Device | Predicate Device | Reference Device | Remark | | Delivery
device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Same | | Output
intensity level | 3 | Unknown | 5 | 5 | Different | | Software/
Firmware/
Microprocess
or Control? | Yes | Yes | Yes | Yes | Same | | Additional features | | | | | | | Electrical
safety | ANSI
ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57
IEC 60601-2-83
AAMI | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57 | Similar | | Eye safety | IEC 62471 | IEC 62471 | Unknown | IEC 62471 | Same | | Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same | {6}------------------------------------------------ {7}------------------------------------------------ #### Performance Data VIII. 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 Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including: - > ISO 10993-5:2009, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity - > ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization #### 2) Electrical Safety and EMC Electrical safety and EMC testing was performed to, and passed, as per the following standards: - > ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance {8}------------------------------------------------ - > IEC 60601-1-2 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 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 Medical electrical equipment -- Part 2-57: Particular 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 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and es… --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT/K223618](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT/K223618) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com