(176 days)
{"predicated_device_k_den_numbers": "K221328"}
Not Found
No
The device is a personal lubricant and the description focuses on its chemical composition, packaging, and biocompatibility testing. There is no mention of AI or ML.
No.
The primary purpose of this device is lubrication and moisturizing for intimate sexual activity, which does not fall under the typical definition of a therapeutic device designed to treat or prevent a disease or condition.
No
The device is a personal lubricant intended to lubricate and moisturize, enhance comfort during intimacy, and supplement natural lubrication, not to diagnose medical conditions.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its chemical composition and packaging.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Joylux Intimacy Gel is a personal lubricant for penile and/or vaginal application to lubricate, moisturize, enhance comfort during sexual activity, and supplement natural lubrication. This is a topical application for physical comfort and function.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body to analyze biological samples.
- Device Description: The description details the gel's composition and packaging, which are consistent with a personal lubricant, not a diagnostic test kit or instrument.
- Performance Studies: The performance studies focus on biocompatibility, shelf life, and condom compatibility, all relevant to a personal lubricant applied to the body, not to the analysis of biological samples.
The information provided clearly indicates that this device is a personal lubricant intended for direct application to the body, not for testing biological samples in vitro.
N/A
Intended Use / Indications for Use
The Joylux Intimacy Gel is a water-based personal lubricant for vaginal application, intended to lubricate and moisturize, 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.
Product codes
NUC
Device Description
Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.
The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Biocompatibility: Biocompatibility testing on the subject lubricant was performed in accordance with the 2023 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. Tests included Cytotoxicity (ISO 10993-5:2009/(R)2014), Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021), Vaginal Irritation (ISO 10993-23: 2021), and Acute Systemic Toxicity (ISO 10993-11:2017). The results supported the biocompatibility of the device.
Shelf Life: The subject device has a 24-month shelf-life, determined by real-time and accelerated aging study per ASTM F1980-21. Device specifications listed in Table 1 were tested across the shelf-life and met 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. The results showed compatibility with natural rubber latex and polyisoprene condoms, but not with polyurethane condoms.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5300 Condom.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 20, 2025
Joylux, Inc % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K242958
Trade/Device Name: Joylux Intimacy Gel (PG3100) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Received: February 20, 2025
Dear Prithul Bom:
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"
1
(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-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
2
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,
Michael T. Bailey -S
For
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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Indications for Use
510(k) Number (if known) K242958
Device Name Joylux Intimacy Gel (PG3100)
Indications for Use (Describe)
The Joylux Intimacy Gel is a water-based personal lubricant for vaginal application, intended to lubricate and moisturize, 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) |
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510(k) Summary – K242948 Joylux Intimacy Gel (PG3100)
l. General Information on Submitter
| Applicant:
Address:
Telephone:
Contact Person:
Contact Title:
Email: | Joylux, Inc.
120 Lakeside Avenue, Suite
300, Seattle, WA 98122 USA
206-219-6444
Colette Courtion
CEO info@joylux.com |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent Information | |
| Contact Person: | Sarah Lacey Robbins
Quality Manager / Quality & Regulatory
Consultant, Rook Quality Systems,
1155 Mount Vernon Hwy, Suite 800
Dunwoody, GA 30338 |
| Phone: | 813-220-3686 |
| Email: | sarah.robbins@rookqs.com |
| Date Prepared: | March 19, 2025 |
| Device Information | |
| Trade Name: | Joylux Intimacy Gel (PG3100) |
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number | 21 CFR 884.5300 |
| Device Class: | II |
| Product Code: | NUC (Lubricant, Personal) |
Predicate Device IV.
II.
III.
| Predicate Device | 510(k) Number |
|---|---|
| Bloomi Smooth Water Based Lubricant | K221328 |
The predicate device has not been subject to a design-related recall.
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V. Description of Device
Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.
The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.
The specifications for Joylux Intimacy Gel are described in Table 1.
| Parameter | Test
Method | Specification |
|---------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance/Color | Visual | Clear, colorless |
| Odor | Olfactory | Odorless |
| pH | USP | 4.0-5.0 |
| Viscosity | USP | 900-7800 |
| Osmolality | USP | 250-420 mOsm/kg (1:10 dilution factor) |
| Antimicrobial Effectiveness | USP | Meets USP acceptance criteria for
Category 2 products. Bacteria: not less
than 2.0 log reduction from the initial
count at 14 days, and no increase from
14-days count at 28 days.
Yeasts and Molds: no increase from the
initial calculated count at 14 and 28
days. |
| Total Aerobic Microbial Count
(TAMC) | USP | Less than 10 cfu/mL |
| Total Yeast and Mold Count
(TYMC) | USP | Less than 10 cfu/mL |
| Absence of Pathogenic
Organisms (Candida
albicans, Pseudomonas
aeruginosa, Staphylococcus
aureus) | USP | Absent |
Table 1. Device Specifications
VI. Indications for Use
The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, enhance the ease and
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K242948 Page 3 of 5
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.
VII. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The following table compares the intended use and technological characteristics of the subject and predicate device:
| Characteristic /
Feature | Joylux Intimacy Gel (subject
device) | Bloomi Smooth Water Based
Lubricant (predicate device) -
K221328 | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for use | The Joylux Intimacy Gel is a water-
based personal lubricant for penile
and/or vaginal application, intended
to lubricate and moisturize, 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. | The Bloomi Smooth Water Based
Personal Lubricant is a water-based
personal lubricant for penile and/or
vaginal application, intended to
lubricate and moisturize, 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. | The subject
and predicate
devices have
the same
intended use. |
| Water-Based
Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Not a
contraceptive or
Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Ingredients | DI Water, Hydroxyethylcellulose,
Polyquaterium-5, Propylene Glycol,
PEG-45, Aloe Vera 200x Powder,
Sodium Hyaluronate, Geogard Ultra
(gluconolactone & sodium benzoate) | Water, Microcare SB, Microcare
SB, Hydroxyethylcellulose,
Cyamopsis Tetragonoloba
(Guar) Gum, Citric Acid,
Sodium Hyaluronate, Organic
Helianthus (Sunflower) Seed
Extract, Organic Camellia
Sinensis Leaf
(Green Tea) Extract. | Different |
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| Microbial Limits | TYMC