(22 days)
TargetCool™ (Cooling mode / Boosting mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
TargetCool™ (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device, nozzle, a guard, a filter, and a cartridge.
The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1°C and lasts for more than 1 second, the status light blinks in blue with a beep sound.
N/A
FDA 510(k) Clearance Letter - TargetCool™ (RM-DT02W)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
RecensMedical Inc.
Yeonui Lee
#507, #908, SK V1 center, 830 Dongtansunhwan-daero
Hwaseong-si, Gyeonggi-do 18468
Republic Of Korea
Re: K253114
Trade/Device Name: TargetCool™ (RM-DT02W)
Regulation Number: 21 CFR 878.4350
Regulation Name: Cryosurgical Unit And Accessories
Regulatory Class: Class II
Product Code: GEH, MLY
Dated: September 24, 2025
Received: September 24, 2025
Dear Yeonui Lee:
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 (the 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.
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).
October 16, 2025
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K253114 - Yeonui Lee
Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
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K253114 - Yeonui Lee
Page 3
Colin Kejing Chen
Digitally signed by Colin K. Chen -S
Date: 2025.10.16 20:56:38 -04'00'
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
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K253114
Please provide the device trade name(s).
TargetCool™
Please provide your Indications for Use below.
TargetCool™ (Cooling mode / Boosting mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
TargetCool™ (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Page 5
510(k) Summary
1. ADMINISTRATIVE INFORMATION
Manufacturer Name: RecensMedical, Inc.
#507, #908, SK V1 center, 830 Dongtansunhwan-daero, Hwaseong-si, Gyeonggi-do,
Republic of Korea
Phone: +82 31 8043 3064
Fax: +82 31 630 2092
Date of the summary preparation: September 22, 2025
Contact person: Yeonui Lee / Regulatory Affairs Manager
yui.lee@recensmedical.com
2. DEVICE NAME AND CLASSIFICATION
Trade name: TargetCool™
Common name: Cryosurgical Device
Classification name: Cryosurgical Unit and Accessories
Classification Regulations: 21 CFR 878.4350 / 21 CFR 878.4810
Class: Class II
Classification Panel: General & Plastic Surgery
Product code: GEH, MLY
3. PRIMARY PREDICATE DEVICE
510(k) Number: K230599
Trade name: TargetCool™
Classification name: Cryosurgical Unit and Accessories
Classification Regulations: 21 CFR 878.4350
Class: Class II
Classification Panel: General & Plastic Surgery
Product code: GEH, MLY
Page 1 of 5
Page 6
4. INDICATIONS FOR USE
TargetCool™ (Cooling mode, Boosting) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
TargetCool™ (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
6. DEVICE DESCRIPTION
TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device, nozzle, a guard, a filter, and a cartridge.
The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1°C and lasts for more than 1 second, the status light blinks in blue with a beep sound.
7. PERFORMANCE DATA
The Company's Performance Data for TargetCool™ is as follows:
Bench Testing
TargetCool™ complies with all applicable standards, including ISO 13485:2016, IEC 60601-1 for electrical safety, and IEC 60601-1-2 for electromagnetic compatibility. The device hazard analysis was completed and risk-control measures were implemented to mitigate identified hazards. Performance testing confirmed compliance with the addition of the 120g cartridge and the charging display modification. The testing results further support that all specifications met the acceptance criteria of each module and the interactions of processes. TargetCool™ passed all testing and substantiates the claims of substantial equivalence and safe operation.
Page 2 of 5
Page 7
8. SUBSTANTIAL EQUIVALENCE
The comparison chart below provides evidence to support the equivalence determination between TargetCool™ and the predicate device (K230599) with respect to intended use, technological characteristics and principles of operation. TargetCool™ shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate device.
[TargetCool™-Cooling mode, Boosting mode]
| Product Name | TargetCool™ (Subject Device) | TargetCool™ (K230599) | Comparison |
|---|---|---|---|
| Indications for Use / Intended Use | TargetCool™ is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch). | TargetCool™ is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch). | Same |
| Component | Main system, Control button, LCD, Cooling Nozzle, Freezing Nozzle, Guard, filter, CO2 cartridge and Boosting accessories (Boosting Nozzle, a Boosting guard, and a Boosting Container). | Main system, Control button, LCD, Cooling Nozzle, Freezing Nozzle, Guard, filter, CO2 cartridge and Boosting accessories (Boosting Nozzle, a Boosting guard, and a Boosting Container). | Same |
| Mechanism of Action | The unit blows very low-temperature gas and cold-water at temperature and time settings, onto the desired treatment area | The unit blows very low-temperature gas and cold-water at temperature and time settings, onto the desired treatment area | Same |
| Mode type | Cooling Mode, Boosting Mode | Cooling Mode, Boosting Mode | Same |
| Cryogen Type | CO2, Cold-water (Saline solution) | CO2, Cold-water (Saline solution) | Same |
| Temperature | 2-4 °C within 5 sec | 2-4 °C within 5 sec | Same |
| Treatment Duration | Cooling Mode: Continuous (0 sec), PL (2 sec pre-set), 1 | Cooling Mode: Continuous (0 sec), PL (2 sec pre-set), 1 | Difference |
| Gas Volume | 65g cartridge, 120g cartridge | 65g cartridge | Difference |
| Safety feature | Alarm and status light blinking if the temperature of the skin is determined to be less than -1 °C for 1 second. | Alarm and status light blinking if the temperature of the skin is determined to be less than -1 °C for 1 second. | Same |
The Cooling mode & Boosting mode of TargetCool™ is equivalent in intended use, principles of operation, and performance temperature to TargetCool™ (K230599) and raises no new issues of safety or effectiveness.
Page 3 of 5
Page 8
The difference from the predicate device is the addition of a 120 g CO₂ cartridge. This change increases the volume of CO₂ gas, thereby extending the treatment duration while maintaining the same temperature performance as the original device. Therefore, this difference does not raise new questions regarding safety or effectiveness.
[TargetCool™-Freezing mode]
| Product Name | TargetCool™ (Subject Device) | TargetCool™ (K230599) | Comparison |
|---|---|---|---|
| Indications for Use / Intended Use | TargetCool™ are intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures- Molluscum Contagiosum- Skin Tags- Actinic Keratosis- Lentigo- Verruca Plana- Verruca Vulgaris- Verruca Lesions- Genital Lesions- Seborrheic Keratosis | TargetCool™ are intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures- Molluscum Contagiosum- Skin Tags- Actinic Keratosis- Lentigo- Verruca Plana- Verruca Vulgaris- Verruca Lesions- Genital Lesions- Seborrheic Keratosis | Same |
| Component | Main system, Control button, LCD, Cooling Nozzle, Freezing Nozzle, Guard, filter, CO2 cartridge and Boosting accessories (Boosting Nozzle, a Boosting guard, and a Boosting Container). | Main system, Control button, LCD, Cooling Nozzle, Freezing Nozzle, Guard, filter, CO2 cartridge and Boosting accessories (Boosting Nozzle, a Boosting guard, and a Boosting Container). | Same |
| Mechanism of Action | Cryogen, CO2 is delivered to the treatment site to effect cellular destruction | Cryogen, CO2 is delivered to the treatment site to effect cellular destruction | Same |
| Temperature | CO2 (-79°C) | CO2 (-79°C) | Same |
| Gas dispensing rate | 0.578 g/sec | 0.578 g/sec | Same |
| Gas Volume | 65g cartridge, 120g cartridge | 65g cartridge | Difference |
| Tissue damage | Cell necrosis occurs only inside the ice ball | Cell necrosis occurs only inside the ice ball | Same |
Cryoablation is the fundamental technological principle for the freezing mode of the subject device, and the predicate devices (TargetCool™).
The Freezing mode of TargetCool™ is equivalent in intended use, principles of operation, and performance temperature to TargetCool™ (K230599) and raises no new issues of safety or effectiveness. The difference from the predicate device is the addition of a 120 g CO₂ cartridge. This change increases the volume of CO₂ gas, thereby extending the treatment duration while maintaining the same temperature performance as the original device. Therefore, this difference does not raise new questions regarding safety or effectiveness.
Page 4 of 5
Page 9
8. CONCLUSION
TargetCool™ and the legally marketed predicate devices have the same intended use, Indications for Use statement and the technological characteristics. Performance testing data established that the TargetCool™ is safe and effective as the legally marked predicate devices and that the TargetCool™ does not raise any different questions of safety and effectiveness than the predicate.
On this basis and in accordance with 21 CFR§ 807.100(b), TargetCool™ is substantially equivalent to the predicate device.
Page 5 of 5
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.