Spectrum Laser/IPL

GUDID 00860564000317

ROHRER AESTHETICS, LLC

Multi-modality skin surface treatment system generator

• Primary Device ID: 00860564000317
• NIH Device Record Key: 3ef2f223-4827-44c6-ad4a-912b358b17de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectrum Laser/IPL
• Version Model Number: Spectrum
• Company DUNS: 083701842
• Company Name: ROHRER AESTHETICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860564000317 [Primary]

FDA Product Code

• ONE: Powered Light Based Non-Laser Surgical Instrument

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: 2018-03-29
• Device Publish Date: 2016-09-22

Devices Manufactured by ROHRER AESTHETICS, LLC

• 00860564000324 - Phoenix CO2: 2019-02-07 The equipmnent is used for- human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecolo
• 00860564000317 - Spectrum Laser/IPL: 2018-03-29
• 00860564000317 - Spectrum Laser/IPL: 2018-03-29