Stellar™ M22

GUDID 07290109145167

LUMENIS LTD.

Multi-modality skin surface treatment system

• Primary Device ID: 07290109145167
• NIH Device Record Key: 22e2388f-67c5-4c41-9394-e40b1985bf13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stellar™ M22
• Version Model Number: Stellar LMX, AES
• Company DUNS: 600166524
• Company Name: LUMENIS 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109145167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193500

FDA Product Code

• ONG: Powered Laser Surgical Instrument With Microbeam\Fractional Output

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: 2021-03-12
• Device Publish Date: 2021-03-04

Devices Manufactured by LUMENIS LTD.

• 07290118853701 - Lumenis Pulse 60H, 60Hz: 2023-12-18
• 07290109144924 - Stellar SapphireCool LG 6mm: 2023-08-16
• 07290109144931 - Stellar SapphireCool LG 15x35: 2023-08-16
• 07290109144948 - Stellar SapphireCool LG 8x15: 2023-08-16
• 07290109146676 - SurgiTouch Scanner: 2022-09-30
• 07290109146133 - UltraPulse® DUO: 2022-09-28 UltraPulse DUO
• 07290109147055 - VersaPulse PowerSuite 80/100W: 2022-09-27
• 07290109147062 - VersaPulse PowerSuite 80/100W: 2022-09-27