Who is the manufacturer of Claritag Advanced?

Dgi Technologies filed the 510(k) submission for Claritag Advanced (K222356).

What is the FDA product code for Claritag Advanced?

GEH. It is classified under 21 CFR 878.4350 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Claritag Advanced?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Claritag Advanced?

Freeze'n Clear Skin Clinic Warts & Tags (K211099); Claritag (Rx) (K190747).

Who can help prepare an FDA 510(k) submission like Claritag Advanced?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Claritag Advanced

K222356 · Dgi Technologies · GEH · May 18, 2023 · General, Plastic Surgery

Device Facts

Record ID	K222356
Device Name	Claritag Advanced
Applicant	Dgi Technologies
Product Code	GEH · General, Plastic Surgery
Decision Date	May 18, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4350
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 years or older.

Device Story

Portable, hand-operated cryosurgical device for OTC skin tag removal. System comprises handheld device, base, and 'squeeze and freeze' heads with foam treatment pads. Operation: user places heads into base to activate, then applies cold-saturated foam pads to skin tag for 20 seconds (repeated twice). Mechanism: extreme cold freezes tissue, causing cell death and vascular stasis. Includes blue tint indicator in foam pads to signal freezing temperature. Intended for patient self-use. Benefits: non-invasive removal of skin tags. Safety: device is a flammable aerosol; requires caution regarding pressure and temperature.

Clinical Evidence

Bench testing only. Included biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993), mechanical integrity testing (ASTM F882-84(2002)), effective duration testing, and temperature testing. Human factors validation study performed to confirm safe OTC use.

Technological Characteristics

Portable aerosol cryosurgical unit. Materials meet ISO 10993 requirements. Cryogen: HP152a. Form factor: handheld device with base and foam applicator tips. Energy source: pressurized gas. Mechanical operation: manual activation via base. No software or electronic components.

Indications for Use

Indicated for OTC treatment of skin tags in adults age 21 years or older. Contraindicated for individuals with diabetes, poor blood circulation, or blood conditions affected by extreme cold.

Regulatory Classification

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.

Predicate Devices

Freeze'n Clear Skin Clinic Warts & Tags (K211099)
Claritag (Rx) (K190747)

Related Devices

K240226 — Pixie Skin Tag · Oystershell NV · Oct 18, 2024
K190747 — Claritag · Dgi Technologies · Oct 31, 2019
K242803 — Compound W Skin Tag Remover · Medtech Products, Inc. · Nov 6, 2024
K211099 — Freezen Clear Skin Clinic Warts & Tags · Cryoconcepts LP · Jun 17, 2022
K253000 — CryoFreeze Wart and Skin Tag Remover · Cryosurgery, Inc. · Oct 16, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 02, 2023 DGI Technologies % Marc C. Sanchez, Esq. Regulatory Counsel Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty) 1717 Pennsylvania Ave NW Suite 1025 Washington, District of Columbia 20006 Re: K222356 Trade/Device Name: Claritag Advanced Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dear Marc Sanchez: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 18, 2023. Specifically, FDA is updating this SE Letter as an administrative correction, to revise the incorrect contact information on the original SE letter. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark Trumbore, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 301-796-5436, Mark.Trumbore@fda.hhs.gov. Sincerely, Digitally signed by Mark Mark Trumbore -S Trumbore -S 0ate: 2023.06.02 Mark Trumbore, 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration. The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. May 18, 2023 DGI Technologies % Russ Olsen VP Global QA/RA Healthy Policy Associates 690 Canton Street Suite 302 Westwood, Massachusetts 02090 Re: K222356 Trade/Device Name: Claritag Advanced Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: April 19, 2023 Received: April 19, 2023 Dear Russ Olsen: 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. 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 {2}------------------------------------------------ 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 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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/odrh-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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, | Mark Trumbore -S | Digitally signed by Mark Trumbore -S Date: 2023.05.18 11:19:29 -04'00' | |---------------------|---------------------------------------------------------------------------------| |---------------------|---------------------------------------------------------------------------------| Mark Trumbore, 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) K222356 Device Name Claritag Advanced Indications for Use (Describe) The Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 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) #### 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." {4}------------------------------------------------ #### 510(k) Summary The following information is provided as required by 21 CFR 807.92 for the Claritag Advanced 510(k) premarket notification. | Trade Name of Device: | Claritag Advanced | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name of Device: | Portable aerosol cryosurgery device | | Sponsor: | DGI Group, LLC 400 Candelwood Commons Howell, NJ 07731 Telephone: 732-887-5087 | | Contact person: | Marc C. Sanchez, Esq. Regulatory Counsel 1717 Pennsylvania Ave. NW, Suite 1025 Washington, D.C. 20006 (202) 765-4491 msanchez@fdaatty.com | Date: May 17, 2023 Device Class: II Regulation Name and Number: 878.4350 Panel: Office of Health Technology 4, Division of Health Technology 4 A Product Code: GEH Predicate: K211099 #### Device Description The Claritag Advanced is a portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system. The cryogen application methodology for skin tag removal is a widely accepted practice used by physicians for decades. The mechanism of action for cryotherapy are the direct effects of freezing on the cells, and the vascular stasis which develops in the tissue after thawing. Image /page/4/Picture/9 description: The image shows a white Claritag stamp with the word "Claritag" printed vertically in blue on the front. The stamp has a unique design with a textured grip on the sides and a sturdy base. The stamp appears to be new and unused. The Claritag® Kit contains the Claritag handheld device and the Claritag Base. The {5}------------------------------------------------ Claritag device houses the Claritag® "squeeze and freeze" heads with foam treatment pads and liquid cooling gas. A spare set of treatment heads is included. The Claritag Base will activate the freezing once the heads are placed into the base. Pressing down on the base sends the liquid cooling gas to the Claritag "squeeze and freeze heads." Instructions for Use are included. # Intended Use: The Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 years or older. # Non-Clinical Test Reports The following tests were performed on the Claritag Advanced device and the test results show that the subject device is substantially equivalent to the predicate Device. ## Biocompatibility: - O Cytotoxicity - Sensitization O - Irritation 0 ### Performance testing - Mechanical Integrity Testing (as outlined in ASTM F882-84(2002) 0 - Effective Duration Test O - Temperature Testing 0 Human Factors: A human factors validation test was performed on the Claritag Advanced device and the test results show that the subject device is substantially equivalent to the predicate Device. ## Summary of Substantial Equivalence The Claritag Advanced and the predicate are for similar uses and rely on the same mode of action. Both devices use cryogenic gases. The cryogenic gas in the Claritag Advanced device was chosen as HP152A due to its safety characteristics as compared with DMEP ("DME") in the Freeze'n Clear device. {6}------------------------------------------------ ### Table 1 Technological Characteristics | | Subject Device | Primary Predicate | Secondary Predicate | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Claritag (OTC) | Freeze'n Clear Skin Clinic Warts & Tags | Claritag (Rx) | | | DGI Technologies | CryoConcepts (sold by Dr. Scholl's ) | DGI Technologies | | Characteristic | K222356 | K211099 | K190747 | | Intended Use | Skin Tags | Warts & Skin Tags | Skin Tags | | | OTC | OTC | Rx | | Cryogen | HP152a | DMEP | HP152a | | Contents | Canisters containing cryogen Foam tips in plastic holder to protect surrounding skin | Canister containing cryogen Foam applicator Tweezers to hold up skin tag | Canisters containing cryogen Foam tips in plastic holder to protect surrounding skin | | Mechanism of Action | Extreme cold freezes skin tag | Extreme cold freezes skin tag or wart | Extreme cold freezes skin tag | | Time to freeze skin tag | 20 seconds, 2 times | 40 seconds | 20 seconds, 2 times | | Visible safety indicator of freezing temperature | Blue tint in foam pads | None | Blue tint in foam pads | | Safety Conditions | Do not puncture or destroy gas canister Flammable aerosol. Pressurized canister. May burst if heated. Do not expose to temperatures exceeding 400C/1200F Do not smoke or use near an open flame | Do not puncture or incinerate gas canister Do not expose to heat or store at temperatures above 1200F Do not smoke while using the product. Keep away from fire or flame. | Do not puncture or destroy gas canister Flammable aerosol. Pressurized canister. May burst if heated. Do not expose to temperatures exceeding 400C/1200F Do not smoke or use near an open flame | | Treatment Procedure | Push down on the canister until hissing sound starts and stops and foam tips turn blue. Place the tips around the tag and squeeze for 20 sec. Repeat. | Spray the cryogen into the applicator to saturate it and then place it directly onto the lesion for 40 sec. | Push down on the canister until hissing sound starts and stops and foam tips turn blue. Place the tips around the tag and squeeze for 20 sec. Repeat. | | Number of Treatments | 10 | 8 | 10 | | Disposal | Entire unit is disposable after emptied of cryogen | Entire unit is disposable after emptied of cryogen | Entire unit is disposable after emptied of cryogen | {7}------------------------------------------------ | Outer Box Label - Intended Use | Skin Tag Removal Device | Skin Tag Remover in as little as 1 treatment | Skin Tag Removal Device | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Outer Box Label - Exclusion Criteria | Do not use if you are diabetic, have poor blood circulation, or have been diagnosed with blood conditions affected by extreme cold or if younger than 18 years old | Do not use if you are diabetic, have poor blood circulation, or have been diagnosed with blood conditions affected by extreme cold or if younger than 21 years old | Do not use if you are diabetic, have poor blood circulation, or have been diagnosed with blood conditions affected by extreme cold | | Outer Box Label - Warnings | Keep out of reach of children. For External Use Only. Flammable Aerosol. Presurized container. May burst if heated. Keep away from hot surfaces, sparks open flames and other ignition sources. Do not expose to temperatures exceeding 400C/1200F. (Inside labeling includes all the other predicate warnings.) | Keep out of reach of children. For External Use Only. Avoid contact with eyes. Avoid inhaling and use only in well ventilated areas. Do not eat. For external use only. Use only as directed. Do not spray gas directly onto skin. Misuse of this product may result in burns and scarring of healthy tissue or blindness. | Keep out of reach of children. For External Use Only. Flammable Aerosol. Presurized container. May burst if heated. Keep away from hot surfaces, sparks open flames and other ignition sources. Do not expose to temperatures exceeding 400C/1200F. (Inside labeling includes all the other predicate warnings.) | | Biocompatibility | Meets ISO 10993 Requirements | Meets ISO 10993 Requirements | Meets ISO 10993 Requirements | ### Conclusion: Therefore, taking into consideration Table 1 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the Claritag Advanced raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device.