Isolaz 40-01230

GUDID 00816995020493

SM ISR ST I-IV 500

SOLTA MEDICAL

Multi-modality skin surface treatment system

• Primary Device ID: 00816995020493
• NIH Device Record Key: b3a6d5f0-d8a2-40da-b228-0e9431438fb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolaz
• Version Model Number: 40-01230
• Catalog Number: 40-01230
• Company DUNS: 079999584
• Company Name: SOLTA MEDICAL
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00816995020493 [Primary]

FDA Product Code

• GEX: Powered 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: 4
• Public Version Date: 2018-11-05
• Device Publish Date: 2016-09-23

On-Brand Devices [Isolaz]

• 00816995020622: PROFUSION 1 TIP + 30C PK
• 00816995020615: TIP, PROFUSION, MACH XL WITH SOFTWARE
• 00816995020608: MD ISR ST IV-VI 600
• 00816995020592: SM ISR ST IV-VI 500
• 00816995020585: MD IAC ST IV-VI 1200
• 00816995020578: SM IAC ST IV-VI 375
• 00816995020561: ISOLAZ TIP SPRAY 4 PACK
• 00816995020554: ISOLAZ TIP SPRAY 4 PACK, 1234ZE
• 00816995020547: MD IAC ST I-IV 1200
• 00816995020530: SM IAC ST I-IV 375
• 00816995020523: MD ISR ST I-IV 600
• 00816995020516: ISOLAZ 2 SYSTEM, CART-110
• 00816995020509: ISOLAZ 2, CART-110, REFURBISHED
• 00816995020493: SM ISR ST I-IV 500
• 00816995020486: ISOLAZ 2 SYSTEM, CART-220
• 00816995020479: ISOLAZ 2, CART-220, REFURBISHED
• 00816995020462: TIP, CALIBRATION, ISOLAZ 2
• 00816995020455: ASSEMBLY, AMGLO LAMP, ISOLAZ
• 00816995020448: ISOLAZ 2 SYSTEM, CONSOLE
• 00816995020431: ISOLAZ 2, CONSOLE, REFURBISHED
• 00816995020424: ISOLAZ 2 SYSTEM, HANDPIECE
• 00816995020400: ISOLAZ 2,HANDPIECE , REFURBISHED
• 00816995020394: ACCESSORY KIT, ISOLAZ 2
• 00816995020370: LAMP, 400 NM, ISOLAZ 2
• 00816995020363: LAMP, 550 NM, ISOLAZ 2
• 00816995020349: ISOLAZ 2 TREATMENT TIP, ACNE, LARGE, 1 E
• 00816995020332: ISOLAZ 2 TIP, ACNE, LARGE, 4-PK
• 00816995020325: ISOLAZ 2 TREATMENT TIP, ACNE, MEDIUM, 1
• 00816995020301: ISOLAZ 2 TIP, ACNE, MEDIUM, 4-PK
• 00816995020295: ISOLAZ 2 TREATMENT TIP, ACNE, SMALL, 1 E
• 00816995020271: ISOLAZ 2 TIP, ACNE, SMALL, 4-PK
• 00816995020257: ISOLAZ 2 TREATMENT TIP, ACNE, CREDIT, 12
• 00816995020240: ISOLAZ 2 TIP, PROFUSION KIT, 12-PK