SkinStylus

GUDID 00196852554485

The SkinStylus SteriLock® MicroSystem is a powered microneedling device, intended to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

Esthetic Medical Inc

Cosmetic micro-needling electronic handpiece, professional

• Primary Device ID: 00196852554485
• NIH Device Record Key: 7b7049b2-e0f1-4f25-9199-5ddfed767d2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SkinStylus
• Version Model Number: MP1209SL1
• Company DUNS: 105045262
• Company Name: Esthetic Medical Inc
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852554485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200044

FDA Product Code

• QAI: Powered Microneedle Device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-03
• Device Publish Date: 2023-01-12