Cerynë Intimate Care
Device Facts
| Record ID | K250488 |
|---|---|
| Device Name | Cerynë Intimate Care |
| Applicant | Ansella Therapeutics |
| Product Code | NUC · Obstetrics/Gynecology |
| Decision Date | Dec 12, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
Indications for Use
Cerynë Intimate Care is a silicone-based personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Story
Ceryné Intimate Care is a non-sterile, silicone-based personal lubricant. It is applied topically to the vaginal area to provide lubrication and moisture during intimate sexual activity. The device is intended for over-the-counter use by consumers. It functions by reducing friction during sexual activity, thereby enhancing comfort. The lubricant is supplied in 15g and 30g tubes. It is compatible with natural rubber latex and polyisoprene condoms, but incompatible with polyurethane condoms. The device does not act as a contraceptive or spermicide.
Clinical Evidence
Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) per ISO 10993 standards confirmed the device is non-cytotoxic, non-irritating, non-sensitizing, and non-toxic. Shelf-life testing confirmed specifications met over a 2-year period. Condom compatibility testing per ASTM D7661-18 confirmed compatibility with natural rubber latex and polyisoprene, and incompatibility with polyurethane.
Technological Characteristics
Silicone-based lubricant containing Dimethicone, Dimethiconol, 2-Octyldodecanol, Cholesterol, Span 60, Stearic Acid, Tocopheryl Acetate, Arlacel 165, Cetyl Stearyl Alcohol, Sodium Benzoate, Glycogen, L-Lactic Acid, and Water. Specifications: pH 3.5-4.5; Viscosity 25,000–45,000 cPs at 25°C; Osmolality 250–300 mOsm/kg. Tested per USP <791>, <912>, <785>, <51>, <61>, and <62>. Non-sterile. Packaged in 15g/30g tubes.
Indications for Use
Indicated for vaginal application to moisturize and lubricate, enhance comfort during intimate sexual activity, and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane condoms.
Regulatory Classification
Identification
A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
Special Controls
*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
Predicate Devices
- Lifestyles Luxe Premium Personal Lubricant (K122477)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
December 12, 2025
Ansella Therapeutics
Maria Carrasco
Quality Manager
20602 Behrens Pass Lane
Cypress, Texas 77433
Re: K250488
Trade/Device Name: Ceryné Intimate Care
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Regulatory Class: II
Product Code: NUC
Received: November 12, 2025
Dear Maria Carrasco:
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).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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
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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,
Monica D. Garcia -S
Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive, Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K250488
Device Name
Cerynë Intimate Care
Indications for Use (Describe)
Cerynë Intimate Care is a silicone-based personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ 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:
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FORM FDA 3881 (6/20)
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PSC Publishing Services (301) 443-6740
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510(k) Summary – K250488
I. General Information on Submitter
Applicant: Ansella Therapeutics.
Address: 110 CANAL ST FL 4TH, LOWELL, MA, 01852, USA
Telephone: +16892471190
Contact Person: Maria Agustina Duguine Carrasco
Contact Title: Regulatory Affairs
Email: maria.carrasco@ansellatx.com
Date Prepared: December 11, 2025
II. General Information on Device
Proprietary/Trade Name: Ceryné Intimate Care
Common Name: Personal Lubricant
Regulation Name: Condom
Regulation Number: 21 CFR 884.5300
Regulatory Class: II
Product Code: NUC (Lubricant, Personal)
III. Predicate Device
| Predicate Device | 510(k) Number |
| --- | --- |
| Lifestyles Luxe Premium Personal Lubricant | K122477 |
This predicate device has not been subject to a design-related recall.
IV. Description of Device
Ceryne Intimate Care is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Its formulation consists of Dimethicone, Dimethiconol Silicone blend, 2-Octyldodecanol, Cholestrol, Span 60, Stearic Acid, Tocopheryl Acetate, Arlacel 165, Cetyl Stearyl Alcohol, Sodium Benzoate, Glycogen, L-Lactic Acid and Water. This device compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
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The lubricant is packaged in 15g and 30g tubes. The specifications for Ceryné Intimate Care are described in Table 1.
Table 1. Device Specifications
| Parameter | Test Method | Specification |
| --- | --- | --- |
| Appearance/Color | Visual | White smooth cream. |
| Odor | Olfactory | Odorless |
| pH | USP<791> | 3.5-4.5 |
| Viscosity | USP<912> | 25,000–45,000 cPs at 25°C |
| Osmolality | USP<785> | 250 – 300 mOsm/kg |
| Antimicrobial Effectiveness | USP <51> | Meets USP <51> acceptance criteria for Category 2 products. Category 2, bacteria should show not be less than 2.0 log reduction at 14 days and no increase from 14-day Count at the 28 day count. Yeasts and molds should show no increase from the initial calculated count at 14 and 28 days. |
| Total Aerobic Microbial Count (TAMC) | USP<61> | Less than 100 cfu/mL |
| Total Yeast and Mold Count (TYMC) | USP<61> | Less than 10 cfu/mL |
| Absence of Pathogenic Organisms (Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus) | USP<62> | Absent |
V. Indications for Use
Ceryne Intimate Care is a silicone-based personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
VI. Substantial Equivalence Discussion
The following table compares the intended use and key technological characteristics of the subject and predicate device:
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| Characteristic / Feature | Ceryne Intimate Care (subject device) | Lifestyles Luxe Premium Personal Lubricant (predicate device) – K122477 | Comparison |
| --- | --- | --- | --- |
| Indication for use | Ceryne Intimate Care is a silicone-based personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. | Lifestyles(r) luxe(tm) premium personal lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. | Similar |
| Contains water | Yes | No | Same |
| Over the Counter | Yes | Yes | Same |
| Not a contraceptive or Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary Ingredients | Dimethicone, Dimethiconol Silicone blend, 2-Octyldodecanol, Cholestrol, Span 60, Stearic Acid, Tocopheryl Acetate, Arlacel 165, Cetyl Stearyl Alcohol, Sodium Benzoate, Glycogen, L-Lactic Acid and Water | Cyclomethicone, Dimethicone | Different |
| Microbial Limits | Total mold/yeast count <10 cfu/mL
Total aerobic microbial count <100 cfu/mL
Absence of pathogens (Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus) | Total mold/yeast count <10 cfu/mL
Total aerobic microbial count <100 cfu/mL
Absence of pathogens (Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus) | Same |
| Viscosity | 25,000–45,000 cPs at 25°C | 250-400 mPas | Different |
| Osmolality | 250-300 mOsm/kg | NA | Different |
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| pH | 3.5-4.5 | NA | Different |
| --- | --- | --- | --- |
| Condom Compatibility | This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. | This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms. | Different |
The subject and predicate devices have similar indications for use and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different questions of safety and effectiveness.
## VII. Summary of Non-Clinical Performance Testing
### Biocompatibility
Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009/(R)2014)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021)
- Vaginal Irritation (ISO 10993-23: 2021)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of this testing demonstrate that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
### Shelf Life
The subject device is a non-sterile personal lubricant packaged in 15g and 30g tubes with a 2-year shelf-life in accordance with the results of real time aging study. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.
### Condom Compatibility
The subject device was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results show that Ceryné Intimate Care is compatible with natural rubber latex and
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polyisoprene condoms. Ceryné Intimate Care is not compatible with polyurethane condoms.
## VIII. Conclusion
The results of the testing described above demonstrate that Ceryné Intimate Care is as safe and effective as the predicate device and supports a determination of substantial equivalence.
