SensiLight - grey

GUDID 05060445340005

The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

EL GLOBAL TRADE LTD

Intense pulsed light skin surface treatment system

• Primary Device ID: 05060445340005
• NIH Device Record Key: dab13b6e-af0f-46cc-b152-956b37dcc534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SensiLight - grey
• Version Model Number: IPL050US01SNS
• Company DUNS: 649726981
• Company Name: EL GLOBAL TRADE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com
• Phone: 855-736-7422
• Email: support@sensica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060445340005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140381

FDA Product Code

• OHT: Light Based Over-The-Counter Hair Removal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-07
• Device Publish Date: 2016-10-19

Devices Manufactured by EL GLOBAL TRADE LTD

• 05060445341569 - Sensilight Mini - bronze: 2021-10-19 The Sensilight Mini is an over the counter device intended for the removal of unwanted hair. The Sensilight Mini is also intende
• 05060445341576 - Sensilight Pro - bronze: 2021-10-19 The Sensilight Pro is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is
• 05060445340005 - SensiLight - grey: 2020-02-07The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
• 05060445340005 - SensiLight - grey: 2020-02-07 The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for per
• 05060445340012 - SensiLight - mint: 2020-02-07 The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for per
• 05060445340029 - SensiLight - salmon: 2020-02-07 The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for per
• 05060445340043 - SensiLight Mini - mint: 2020-02-07 The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intend
• 05060445340050 - SensiLight Mini - blue: 2020-02-07 The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intend
• 05060445341118 - sensiFirm: 2020-02-07 The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massag