Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 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)
Device Facts
| Record ID | K241998 |
|---|---|
| Device Name | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 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) |
| Applicant | Shenzhen Ulike Smart Electronics Co., Ltd. |
| Product Code | OHT · General, Plastic Surgery |
| Decision Date | Dec 13, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Device Story
Over-the-counter, home-use IPL hair removal device; utilizes xenon arc flashlamp to emit light pulses; sapphire treatment window for skin contact; dual-lamp design supports multi-pulse emission. Device features integrated ice cooling for user comfort; skin sensor prevents light emission unless in full contact with skin. Operated by user via finger switch; powered by external adapter. UI20S series includes skin tone recognition. Output intensity adjustable (1-10 levels). Device reduces hair growth by targeting hair follicles below skin surface without cutting/pulling. Benefits include nearly painless hair reduction and long-term regrowth stability.
Clinical Evidence
Bench testing only. Evidence includes biocompatibility (ISO 10993-5, -10, -23), electrical safety/EMC (IEC 60601-1, -1-2, -1-11, -2-57, -2-83), photobiological eye safety (IEC 62471), and usability engineering (IEC 60601-1-6). Software verification and validation confirmed all specifications met and hazards mitigated.
Technological Characteristics
Xenon arc flashlamp IPL source; sapphire treatment window; 550-1200nm wavelength; 1.67-6.67 J/cm² energy density; 1-10 intensity levels; external power adapter (100-240V, 50/60Hz). Includes skin contact sensor and ice cooling system. Biocompatible materials per ISO 10993. Software-controlled pulse delivery.
Indications for Use
Indicated for removal of unwanted hair and permanent reduction in hair regrowth in adults (Fitzpatrick Skin Types I-V).
Regulatory Classification
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
- IPL Hair Removal Device (K230122)
- iPulse Hair Removal System (K130315)
- Hand-held IPL device (IPL Home Use Hair Removal Device) (K230739)
- IPL Hair Removal Device (K240016)
- Ice Cooling IPL Hair Removal Device (K242039)
Related Devices
- K250938 — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) · Shenzhen Ulike Smart Electronics Co., Ltd. · May 23, 2025
- K223618 — IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD · Shenzhen Ulike Smart Electronics Co., Ltd. · Feb 28, 2023
- K251984 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) · Shenzhen Ulike Smart Electronics Co., Ltd. · Jul 24, 2025
- K253881 — Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) · Shenzhen Fansizhe Science and Technology Co., Ltd. · Dec 29, 2025
- K250942 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) · Shenzhen Ulike Smart Electronics Co., Ltd. · Jul 11, 2025
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION" in a smaller font size.
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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2
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
| Predicate<br>Device | Predicate<br>Device 1 | Predicate<br>Device 2 | Predicate<br>Device 3 | Predicate<br>Device 4 | Predicate<br>Device 5 |
|---------------------|-----------------------------------------------------|----------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------|
| 510(k) number | K230122 | K130315 | K230739 | K240016 | K242039 |
| Trade Name | IPL Hair<br>Removal<br>Device | iPulse Hair<br>Removal<br>System | Hand-held IPL<br>device (IPL<br>Home Use<br>Hair Removal<br>Device) | IPL Hair<br>Removal<br>Device | Ice Cooling<br>IPL Hair<br>Removal<br>Device |
| Manufacturer | Shenzhen Ulike<br>Smart<br>Electronics<br>Co., Ltd. | CyDen Ltd | Shenzhen<br>IONKA<br>Medical<br>Technology<br>Co., Ltd. | Shenzhen<br>Jianrong<br>Biomedical<br>Electronics<br>Co., Ltd | Shenzhen Ulike Smart<br>Electronics<br>Co., 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 | Predicate<br>Device 1 | Predicate Device<br>2 | Predicate Device<br>3 | Predicate Device<br>4 | Predicate Device<br>5 | Remark | | | | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-------------|--------------|--------------|----------------------------------------------------------------------------------|--------------|-----------|-----------------------------------------------------------------|
| 510(k) number | / | K230122 | K130315 | K230739 | K240016 | K242039 | / | | | | | | | | | |
| Trade Name | Ice Cooling<br>IPL Hair<br>Removal<br>Device | IPL Hair<br>Removal<br>Device | iPulse Hair<br>Removal System | Hand-held<br>device (IPL<br>Home Use Hair<br>Removal Device) | IPL Hair<br>Removal<br>Device | Ice Cooling IPL<br>Hair Removal<br>Device | / | | | | | | | | | |
| Manufacturer | Shenzhen<br>Ulike Smart<br>Electronics<br>Co., Ltd. | Shenzhen Ulike<br>Smart<br>Electronics<br>Co., Ltd. | CyDen Ltd | Shenzhen IONKA<br>Medical<br>Technology Co.,<br>Ltd. | Shenzhen<br>Jianrong<br>Biomedical<br>Electronics<br>Co., Ltd | Shenzhen Ulike<br>Smart<br>Electronics Co.,<br>Ltd. | / | | | | | | | | | |
| Regulation<br>number | 21 CFR<br>878.4810 | 21 CFR<br>878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR<br>878.4810 | 21 CFR<br>878.4810 | Same | | | | | | | | | |
| Product code | OHT | OHT | OHT | OHT | OHT | OHT | Same | | | | | | | | | |
| Device<br>classification | Class II | Class II | Class II | Class II | Class II | Class II | Same | | | | | | | | | |
| Indication for use/<br>Intended use | Ice Cooling<br>IPL Hair<br>Removal<br>Device with<br>sapphire<br>treatment<br>window is<br>indicated for | IPL Hair<br>Removal<br>Device is<br>indicated for<br>the removal of<br>unwanted hair.<br>The device is<br>also indicated | The iPulse Hair<br>Removal System<br>is<br>an<br>Over-the-counter<br>device intended<br>for the removal of<br>unwanted hair. | IPL Home Use<br>Hair Removal<br>Device is<br>indicated for the<br>removal of<br>unwanted hair.<br>The device is also<br>indicated for the | IPL Hair<br>Removal<br>Device is<br>indicated for<br>the removal of<br>unwanted hair.<br>The device is<br>also indicated | Ice Cooling IPL<br>Hair Removal<br>Device with<br>sapphire<br>treatment<br>window is<br>indicated for the<br>removal of | Same | | | | | | | | | |
| the removal of<br>unwanted hair.<br>The device is<br>also indicated<br>for the<br>permanent<br>reduction in<br>hair regrowth,<br>defined as the<br>long-term,<br>stable<br>reduction in the<br>number of<br>hairs regrowing<br>when measured<br>at 6, 9 and 12<br>months after<br>the completion<br>of a treatment<br>regime. | for<br>the<br>permanent<br>reduction in<br>hair regrowth,<br>defined as the<br>long-term,<br>stable reduction<br>in the number<br>of<br>hairs<br>regrowing<br>when measured<br>at 6, 9 and 12<br>months after<br>the completion<br>of a treatment<br>regime. | OTC | for the<br>permanent<br>reduction in hair<br>regrowth, defined<br>as the long-term,<br>stable reduction<br>in the number of<br>hairs regrowing<br>when measured at<br>6, 9 and 12<br>months after the<br>completion of a<br>treatment regime. | OTC | unwanted hair.<br>The device is<br>also indicated for<br>the permanent<br>reduction in hair<br>regrowth,<br>defined as the<br>long-term, stable<br>reduction in the<br>number of hairs<br>regrowing when<br>measured at 6, 9<br>and 12 months<br>after the<br>completion of a<br>treatment<br>regime. | Same | | | | | | | | | | |
| Prescription or OTC | OTC | OTC | OTC | OTC | OTC | Same | | | | | | | | | | |
| Applicable skin | Fitzpatrick<br>Skin Types I-V | Fitzpatrick<br>Skin Types I-V | unknown | Fitzpatrick Skin<br>Types I-V | unknown | Fitzpatrick Skin<br>Types I-V | Same | | | | | | | | | |
| Treatment area | Large areas | Large areas | leg, arm, bikini | unknown | unknown | Large areas (e.g. | Same | | | | | | | | | |
| | (e.g. arms,<br>legs, chest) and<br>small areas<br>(e.g. lip) | (e.g. arms, legs,<br>chest) and<br>small areas<br>(e.g. lip) | and underarm | | | arms, legs, chest)<br>and small areas<br>(e.g. lip) | | | | | | | | | | |
| Device design | | | | | | | | | | | | | | | | |
| Source energy | Supplied by<br>external<br>adapter | Supplied by<br>external<br>adapter | Supplied by<br>external<br>adapter | Supplied by<br>external<br>adapter | Supplied by<br>external<br>adapter | Supplied by<br>external<br>adapter | Same | | | | | | | | | |
| Power supply | 100-240V~,<br>50/60Hz | 100-240V~,<br>50/60Hz | 100-240V~,<br>50/60Hz | 100-240V~,<br>50/60Hz | 100-240V~,<br>50/60Hz | 100-240V~,<br>50/60Hz | Same | | | | | | | | | |
| Dimension | 206.73mm*68.<br>68mm*54.29m<br>m | 60mm x 38mm<br>x<br>170mm | unknown | FZ-608,<br>FZ-608G:<br>98*147*60(mm)<br>FZ-100:<br>198*71*44(mm)<br>FZ-200:<br>216*68*52(mm) | unknown | 206.73mm*68.6<br>8 mm*54.29mm | SE<br>Note 1 | | | | | | | | | |
| Sterilization | Not required | Not required | Not required | Not required | Not required | Not required | Same | | | | | | | | | |
| Output specification | | | | | | | | | | | | | | | | |
| Light source | Intense Pulsed<br>Light | Intense Pulsed<br>Light | Intense Pulsed<br>Light | Intense Pulsed<br>Light | Intense Pulsed<br>Light | Intense Pulsed<br>Light | Same | | | | | | | | | |
| Energy medium | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Same | | | | | | | | | |
| Wavelength range | 550-1200mm | 560-1200nm | 530-1100nm | 510nm~1200nm | 550-1200nm | 550-1200nm | SE<br>Note 2 | | | | | | | | | |
| Energy density | $1.67~6.67J/cm^2$ | $2.4-7.2J/cm^2$ | $7-10J/cm^2$ | $1.2-4.3J/cm^2$ | $2.79~6.41J/cm^2$ | SE<br>Note 3 | | | | | | | | | | |
| | | | FZ-608,<br>FZ-608G: 3.33 J/cm2<br>FZ-100: 4.5 J/cm2<br>FZ-200: 5.43 J/cm2 | | | | | | | | | | | | | |
| Output energy | | | $6.5~26J$ | | | | $9.9~19.8J$ | $21~30J$ | $5.4~19.35J$ | $10.9J~25J$ | SE<br>Note 4 | | | | | |
| | | | | | | | | FZ-608,<br>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 | | | | | | | | $3.9cm^2$ | | | | $3.3cm^2$ | $3cm^2$ | $4.5cm^2$ | $3.9cm^2$ | SE<br>Note 5 |
| Pulse duration | | | | | | | | $0.88~3.20ms$<br>Multipulse | | | | $1.15-6.2ms$ | Variable -<br>Single pulse 25milliseconds.<br>to Double Pulse 20ms on, 60 ms off | $0.5~0.8 ms$ | unknown | $0.93ms~3.50ms$<br>Single pulse<br>Double pulse<br>Triple pulse |
| Pulsing control | Finger switch | Finger switch | | Finger switch | Finger switch | Finger switch | | Finger switch | | | | Same | | | | |
| Delivery device | Direct<br>illumination to<br>tissue | Direct<br>illumination to<br>tissue | | Direct<br>illumination to<br>tissue | Direct<br>illumination to<br>tissue | Direct<br>illumination to<br>tissue | | Direct<br>illumination to<br>tissue | | | | Same | | | | |
| Output intensity<br>level | 1-10 Levels | 5 Levels | | unknown | FZ-608,<br>FZ-608G: 9 levels<br>FZ-100: 9 levels<br>FZ-200: 6 levels | unknown | | 1-10 Levels | | | | SE<br>Note 7 | | | | |
| Software/Firmware/Microprocess or<br>Control? | Yes | Yes | | Yes | Yes | Yes | | Yes | | | | Same | | | | |
| Additional features | | | | | | | | | | | | | | | | |
| Electrical safety | IEC 60601-1<br>IEC 60601-1-2<br>IEC<br>60601-1-11<br>IEC<br>60601-2-57<br>IEC<br>60601-2-83 | ANSI AAMI<br>ES 60601-1<br>IEC 60601-1-2<br>IEC<br>60601-1-11<br>IEC<br>60601-2-57<br>IEC<br>60601-2-8…
