Lelo Hex Lubricated Natural Rubber Latex Condom
Lelo, Inc.
LELO USA INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006317264 | 3006317264 | LELO USA INC. | 1 | Y | 2026-01-01 | 5799 Fontanoso Way San Jose CA US 95138 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 128252 | 1082560202 | K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | HIS | 2025-03-07 |
| 128252 | 1288692840 | K162511 | LELO RESPECT HEX Natural Rubber Latex Condom | HIS | 2017-01-13 |
| 128252 | 1924719947 | K160644 | Lelo Hex Natural Rubber Latex Condom | HIS | 2016-06-30 |
| 128252 | 1605934064 | K150857 | Banana Gold | HIS | 2015-08-14 |
| 128252 | 1939904591 | K140780 | KEGEL SMART, KEGELSMART PEARL | HIR | 2014-09-10 |
| 128252 | 1950860013 | ||||
| 128252 | 1978504642 | ||||
| 128252 | 1223037062 |
Product Codes Associated With Registrations#
PMN#
GUDID#
HEX Condoms Respect 36 Pack (US_TNR) - The LELO RESPECT HEX Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2017-02-09
HEX Condoms Respect 12 Pack (US_TNR) - The LELO RESPECT HEX Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2017-02-09
HEX Condoms Respect 3 Pack (US_FR_TNR) Euroslot - The LELO RESPECT HEX Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2017-02-09
HEX Condoms Original 12 Pack (US_TNR) - The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2016-09-23
HEX Condoms Original 3 Pack (US_TNR) - The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2016-09-23
HEX Condoms Original 72 Pack (US_TNR) - The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2023-07-10
LELO HEX RE-ENGINEERED LATEX RESPECT CONDOM - 6 PACK - The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2022-05-26
HEX Condoms Original 36 Pack (US_TNR) - The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2022-06-27
LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6 PACK - The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2022-05-27
Intimina Ziggy Cup - A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
2017-11-07
Intimina Lily Cup One - A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
2017-11-07
Intimina Lily Cup Compact Tamaño A - ES - A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
2016-09-21
Intimina Lily Cup Compact size B - EN - A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
2016-09-21
Intimina Lily Cup Compact size A - EN - A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
2016-09-21
Intimina Lily Cup Size B - EN - A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
2016-09-21
Intimina Lily Cup Size A - EN - A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
2016-09-21
Intimina Ziggy Cup 2 - Size A - A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
2022-05-26
Intimina Ziggy Cup 2 - Size B - A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
2022-05-26
Lelo Hex Lubricated Natural Rubber Latex Condom 36’s - The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2025-04-02
Lelo Hex Lubricated Natural Rubber Latex Condom 12’s - The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2025-04-02
Lelo Hex Lubricated Natural Rubber Latex Condom 3’s - The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2025-04-02
Intimina KegelSmart 2 Rechargeable - The Intimina KegelSmart 2 is a pelvic floor muscle exercise device that provides biofeedback and exercise guidance. Each time the device is used it registers the user's pelvic floor muscle contraction strength and automatically sets a strength level, from 1 to 5, for the following session. Each level has a corresponding exercise routine that is communicated to the user with gentle vibrations.
2023-06-26
Tor 3 Violet Dusk - Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasure. The ring shall be able to be placed around the penis at the base, primarily to slow the flow of blood from the erect penile tissue, thus maintaining an erection for a much longer period of time. Plus a vibrator to facilitate human sexual pleasure.
2023-06-26
Tor 3 Base Blue - Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasure. The ring shall be able to be placed around the penis at the base, primarily to slow the flow of blood from the erect penile tissue, thus maintaining an erection for a much longer period of time. Plus a vibrator to facilitate human sexual pleasure.
2023-06-26
Tor 3 Black - Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasure. The ring shall be able to be placed around the penis at the base, primarily to slow the flow of blood from the erect penile tissue, thus maintaining an erection for a much longer period of time. Plus a vibrator to facilitate human sexual pleasure.
2023-06-26
LELO HEX RE-ENGINEERED LATEX RESPECT CONDOM - 6 PACK - The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
2022-05-26
Intimina KegelSmart - A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.
2022-05-26
Intimina KegelSmart - US - A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.
2016-09-21
Lelo Pino Black - External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.
2016-09-21
Lelo Pino Federal Blue - External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.
2016-09-21
Intimina KegelSmart - ML2(EN/IT/SV/FI) - A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.
2016-09-21
Lelo Tor 2 Green - External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.
2016-09-21
Lelo Tor 2 Purple - External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.
2016-09-21
Lelo Tor 2 Black - External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.
2016-09-21