(125 days)
No
The device description and performance studies focus on the physical cryotherapy process and do not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is intended for the over-the-counter treatment of common warts, plantar warts, and skin tags, directly addressing medical conditions.
No
Explanation: The device is intended for the "treatment" of warts and skin tags, not for diagnosis. Its description focuses on the physical application of cryotherapy to remove the lesions.
No
The device description explicitly lists physical components: a pressurized aerosol canister and applicator swabs. This indicates it is a hardware-based device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CryoFreeze Wart and Skin Tag Remover Function: This device directly applies a cryogen to the surface of the skin to freeze and remove warts and skin tags. It does not analyze any bodily fluids or tissues in vitro (outside the body).
The device is a therapeutic device used for the physical removal of lesions, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years or older.
Product codes
GEH
Device Description
The CryoFreeze Wart and Skin Tag Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common, plantar warts, and skin tags. The device includes:
- A pressurized aerosol canister filled with a liquid mixture of the compressed gases dimethyl ether, ● propane, and isobutane
- Applicator swabs
- Detailed instructions, including illustrated descriptions
To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds.
The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and children age 4 years or older (for common and plantar warts)
adults age 22 years or older (for skin tags)
Intended User / Care Setting
laypersons, home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CryoFreeze Wart and Skin Tag Remover underwent comparative performance testing against the reference device, Verruca-Freeze H. The tests included output temperature of cryogen, freeze charge hold time, and visual confirmation of the ice ball. The comparison of test data confirmed that the subject device performs equivalently to the reference device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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March 13, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CryoSurgery, Inc. Ronald Mcdow CEO and Medical Director 5829 Old Harding Pike Nashville, Tennessee 37205
Re: K243487
Trade/Device Name: CryoFreeze Wart and Skin Tag Remover Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: February 12, 2025 Received: February 12, 2025
Dear Ronald Mcdow:
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"
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(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 OS 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 Rue"). 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-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.
For comprehensive regulatory information about mediation-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).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature of James H. Jang. The signature includes the name "James H. Jang -S" on the left side of the image. On the right side, it states that the signature is digitally signed by James H. Jang -S, with a date of 2025.03.13 and a timestamp of 11:38:50 -04'00'.
Long Chen, Ph.D. 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
3
Indications for Use
510(k) Number (if known) K243487
Device Name
CryoFreeze Wart and Skin Tag Remover
Indications for Use (Describe)
The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years or older.
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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Image /page/4/Picture/0 description: The image shows the logo for Cryosurgery, Inc. The logo is in blue and features a stylized letter C on the left. The words "RYOSURGERY, INC." are to the right of the C.
510(k) Summary
-
- Submission Sponsor CryoSurgery, Inc. 5829 Old Harding Pike Nashville, TN 37205 (615) 354-0414 info@cryosurgeryinc.com 2. Contact Person Ronald McDow 5829 Old Harding Pike Nashville, TN 37205 (615) 354-0414 3. Date Prepared Updated 03/07/2025 4. Device Identification
| Trade / Proprietary Name | CryoFreeze Wart and Skin Tag Remover |
|---|---|
| Common / Used Name | OTC Cryosurgical Device |
| Regulation | 878.4350 - Cryosurgical unit and accessories |
| Product Code | GEH |
| Class | 2 |
-
- Predicate Device
| Device Name | Freeze 'n Clear Skin Clinic for Warts and Skin Tags |
|---|---|
| 510(k) Number | K211099 |
| Regulation Number | 878.4350 - Cryosurgical unit and accessories |
| Product Code | GEH |
| Class | 2 |
| Reference Device | |
| Device Name | Verruca-Freeze H |
| 510(k) Number | K243454 |
| Regulation Number | 878.4350 - Cryosurgical unit and accessories |
| Product Code | GEH |
| Class | 2 |
7. Description of the Subject Device
The CryoFreeze Wart and Skin Taq Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common, plantar warts, and skin tags. The device includes:
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Image /page/5/Picture/1 description: The image shows the logo for Cryosurgery, Inc. The logo is blue and features a stylized letter "C" on the left side. To the right of the "C" is the text "RYOSURGERY, INC." The text is also in blue and is in a sans-serif font.
- A pressurized aerosol canister filled with a liquid mixture of the compressed gases dimethyl ether, ● propane, and isobutane
- Applicator swabs
- Detailed instructions, including illustrated descriptions
To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds.
The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.
8. Indications for Use
The CryoFreeze Wart and Skin Tag Remover is intended for the counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 or older.
9. Technological Comparison
The subject device has the same technological characteristics as the predicate device. It shares the same intended use, mechanism of action, and design as the predicate device.
Additionally, the subject device has the same technological characteristics, mechanism of action, design as the reference device Verruca-Freeze H.
| Technological
Characteristics | Subject Device:
CryoFreeze Wart and Skin Tag
Remover | Predicate Device:
Freeze 'n Clear
Skin Clinic for Warts and Skin
Tags |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name / Device Name | CryoFreeze™ Wart and Skin Tag
Remover | Skin Clinic Freeze 'n Clear for
Warts and Skin Tags |
| 510(k) Number | K243487 | K211099 |
| Indications for Use | The CryoFreeze Wart and Skin
Tag Remover is intended for use
in the over-the-counter treatment
of common warts and plantar
warts in adults and children age
4 years or older and over-the-
counter treatment of skin tags in
adults age 22 years or older. | The Freeze n' Clear Skin Clinic
for Warts and Skin Tags product
is intended for OTC treatment of
common warts, plantar warts,
and skin tags. |
| Cryogen Material | Mixture of dimethyl ether,
propane, and isobutane | Mixture of dimethyl ether,
propane, and isobutane |
| Freeze Temperature | -55°C | -55°C |
| Design | -Cryogen canister with attached
safety shield
-Foam-tipped applicators
-Disposable tweezers | -Cryogen canister with attached
safety shield
-Foam-tipped applicators
-Disposable tweezers |
| Mechanism of Action | Extreme cold destroys the target
tissue | Extreme cold destroys the target
tissue |
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510(k) Summary
Image /page/6/Picture/1 description: The image shows the logo for "Cryosurgery, Inc.". The logo is in blue and features a stylized "C" that is open on the right side. The text "RYOSURGERY, Inc." is to the right of the "C", with "RYOSURGERY" on the same line as the top of the "C" and "Inc." on the same line as the bottom of the "C".
CryoFreeze Wart and Skin Tag Remover K243487
| Treatment Procedure | Cryogen is dispensed into foam
applicator which is then applied
to the lesion for a specified
number of seconds. | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | -Keep away from fire or flame
-Do not smoke while using the
product | -Keep away from fire or flame
-Do not smoke while using the
product |
| Storage and Safety Conditions | -Do not puncture or incinerate
canister | -Do not puncture or incinerate
canister |
| | -Do not expose to heat or store
at temperatures above 120°F. | -Do not expose to heat or store
at temperatures above 120°F. |
| | -Store at room temperature away
from heat | -Store at room temperature away
from heat |
| Disposal | Entire unit is disposable after
emptied of cryogen. | Entire unit is disposable after
emptied of cryogen. |
| Defined Operators | OTC for consumer use | OTC for consumer use |
10. Non-Clinical Performance Data
CryoFreeze Wart and Skin Tag Remover underwent comparative performance testing against the reference device, Verruca-Freeze H. The tests included output temperature of cryogen, freeze charge hold time, and visual confirmation of the ice ball. The comparison of test data confirmed that the subject device performs equivalently to the reference device.
- Statement of Substantial Equivalence
Based on the information presented, it is concluded that the CryoFreeze Wart and Skin Tag Remover device is substantially equivalent to the predicate device Freeze 'n Clear Skin Clinic for Warts and Skin Tags.