ellacor EL-SYS02

GUDID B933ELSYS02

ellacor System with Micro-Coring Technology includes: Console = EL-CON01 Footswitch = FTS01 Handpiece = EL-HPC01 or EL-HPC02

Cytrellis Biosystems, Inc.

Cosmetic micro-needling electronic handpiece, professional

• Primary Device ID: B933ELSYS02
• NIH Device Record Key: 1f007006-5905-4fc9-9ec9-90b0fdff687a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ellacor
• Version Model Number: EL-SYS02
• Catalog Number: EL-SYS02
• Company DUNS: 078440636
• Company Name: Cytrellis Biosystems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com
• Phone: 8572541725
• Email: customerservice@cytrellis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B933ELSYS02 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202517

FDA Product Code

• QAI: Powered Microneedle Device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-16
• Device Publish Date: 2024-05-08

On-Brand Devices [ellacor]

• B933ELHPC010: Handpiece
• B933ELFTS010: Footswitch
• B933ELCON010: Console
• B933ELCCV01: Cleaning Cover
• B933EL03N011: Triple Needle Cartridge (2-Pack)
• B933EL03N010: Triple Needle Cartridge
• B933ELHPC01R0: Handpiece (Refurbished)
• B933ELFTS01R0: Footswitch (Refurbished)
• B933ELCON01R0: Console (Refurbished)
• B933ELSYS01: ellacor System with Micro-Coring Technology includes: Console = EL-CON02 Handpiece = EL-HPC01 Fo
• B933ELKIT010: Consumables Kit includes the following items: Needle Cartridge (EL-03N01) Biofilter Suction Tube
• B933ELCON02: ellacor Console 1.1
• B933ELCLP011: Suction tubing clip
• B933ELHPC02R0: Handpiece (Refurbished)
• B933ELHPC02: Handpiece
• B933ELCON02R0: Console (Refurbished)
• B933ELSYS02: ellacor System with Micro-Coring Technology includes: Console = EL-CON01 Footswitch = FTS01 Hand
• B933ELKIT02: Consumables Kit includes the following items: Needle Cartridge, V2 (EL-03N02) Biofilter Suction
• B933EL03N02: Triple Needle Cartridge (2-Pack)
• B933EL03N020: Triple Needle Cartridge, V2
• B933ELKIT03: Consumable Kit, 2-Pack includes the following items: Needle Cartridge (EL-03N02) Cleaning Cover
• B933ELCCV00: Cleaning Cover 2-pack