FDA.reportPublic FDA data

Lelo Tor 2 Green

Primary DI
07350022271845
Brand
Lelo Tor 2 Green
Company
Leloi AB
Model
1854
Device description
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.
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LKYDevice, External Penile Rigidity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKYDevice, External Penile RigidityGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350022271845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350022271845073500222718457350022271845

GMDN Terms#

Term, Definition table
TermDefinition
Penile ringA device intended to be applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for vaginal intercourse. It is typically designed as a flexible rubber loop that is placed on the penis (i.e., around its base) to restrict the flow of venous blood leaving the penis during an erection. This device can be used alone or with a penile vacuum pump. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
508701849
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350075023453LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6 PACK34532022-05-27
07350075024085HEX Condoms Original 36 Pack (US_TNR) 40852022-06-27
07350075024993LELO HEX RE-ENGINEERED LATEX RESPECT CONDOM - 6 PACK49932022-05-26
07350075029578HEX Condoms Original 72 Pack (US_TNR) 95782023-07-10
07350075022470HEX Condoms Original 3 Pack (US_TNR)24722016-09-23
07350075022494HEX Condoms Original 12 Pack (US_TNR)24972016-09-23
07350075024979HEX Condoms Respect 3 Pack (US_FR_TNR) Euroslot49792017-02-09
07350075025006HEX Condoms Respect 12 Pack (US_TNR)50062017-02-09
07350075025020HEX Condoms Respect 36 Pack (US_TNR)50202017-02-09
07350075028557Intimina Ziggy Cup 2 - Size B85572022-05-26
07350075028601Intimina Ziggy Cup 2 - Size A86012022-05-26
07350022276093Intimina Lily Cup Size A - EN60932016-09-21
07350022276109Intimina Lily Cup Size B - EN61092016-09-21
07350022276116Intimina Lily Cup Compact size A - EN61162016-09-21
07350075020117Intimina Lily Cup Compact size B - EN01172016-09-21
07350075020308Intimina Lily Cup Compact Tamaño A - ES03082016-09-21
07350075026065Intimina Lily Cup One60652017-11-07
07350075026140Intimina Ziggy Cup61402017-11-07
08852961029796Lelo Hex Lubricated Natural Rubber Latex Condom 3’s3s2025-04-02
08852961029802Lelo Hex Lubricated Natural Rubber Latex Condom 12’s12s2025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850076064013Pump Worx Max Boost - White PD Products, LLCLKY2026-05-01
00850076064020Max Boost Pro Flow - Blue/Clear PD Products, LLCLKY2026-05-01
00850076064037Pipedream Beginner's Power Pump - Black PD Products, LLCLKY2026-05-01
00850076064044Pump Worx Max Boost - Black PD Products, LLCLKY2026-05-01
00850076064051Pipedream Beginner's Power Pump - Blue PD Products, LLCLKY2026-05-01
00850076064068Pump Worx Beginner's Vibrating Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064075Max Boost Pro Flow - White/Clear PD Products, LLCLKY2026-05-01
00850076064082Pump Worx Accu-Meter Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064099Pump Worx Rookie of the Year Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064105Pump Worx Max Boost - Blue PD Products, LLCLKY2026-05-01
00850076064112Pump Worx Silicone Power Pump - Blue PD Products, LLCLKY2026-05-01
00850076064129Pump Worx Silicone Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064136Pump Worx Beginner's Power Pump - Purple PD Products, LLCLKY2026-05-01
00850076064143Pump Worx Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
00850076064150Classix Power PumpPD Products, LLCLKY2026-05-01
00850076064167Pump Worx Beginner's Power Pump - Red PD Products, LLCLKY2026-05-01
00850076064174Classix Vibrating Power Pump - ClearPD Products, LLCLKY2026-05-01
00850076064181Pump Worx Beginner's Power Pump - Smoke/Black PD Products, LLCLKY2026-05-01
00850076064198Pump Worx Pistol-Grip Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064204Pump Worx Max-Width Penis Enlarger - Clear/Black PD Products, LLCLKY2026-05-01
00850076064211Pipedream Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
00850005747079Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747260Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747277Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747284Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747291Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747543Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747550Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747567Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14