Optilite

GUDID 00855430006685

1000 micron fiber assembly with flat tip

Convergent Laser Technologies

General/multiple surgical laser system beam guide, single-use, sterile

• Primary Device ID: 00855430006685
• NIH Device Record Key: a49f8e64-6ef5-42e6-b498-b9c7b7c4c783
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optilite
• Version Model Number: HMA-1010FI
• Company DUNS: 177735305
• Company Name: Convergent Laser Technologies
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855430006685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951760

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

[00855430006685]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-31
• Device Publish Date: 2019-12-23

On-Brand Devices [Optilite]

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• 00855430006487: 800 micron fiber assembly with flat tip
• 00855430006470: 600 micron fiber assembly with flat tip
• 00855430006463: 400 micron fiber assembly with flat tip
• 00855430006456: 200 micron fiber assembly with flat tip
• 00855430006449: 600 micron single-use holmium fiber assembly with flat tip
• 00855430006432: 400 micron single-use holmium fiber assembly with flat tip
• 00855430006425: 200 micron single-use holmium fiber assembly with flat tip
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• 00855430006388: Test Fiber-optic, 600 micron
• 00855430006371: Test Fiber-optic, 400 micron
• 00855430006364: Test Fiber-optic, 200 micron
• 00855430006357: 600 micron angled delivery holmium fiber assembly with quartz cap
• 00855430006340: 600 micron holmium fiber assembly with flat tip
• 00855430006333: 400 micron holmium fiber assembly with flat tip
• 00855430006326: 200 micron holmium fiber assembly with flat tip
• 00855430006319: 1000 micron holmium fiber assembly with flat tip
• 00855430006302: 1000 micron circular 90 degree internal reflection fiber assembly w/ gold cap
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• 00855430006289: 600 micron fiber assembly with flexible cooling sheath
• 00855430006272: 600 micron fiber assembly with flat tip
• 00855430006265: 600 micron blue buffer holmium fiber assembly with flat tip
• 00855430006258: 400 micron blue buffer holmium fiber assembly with flat tip
• 00855430006241: 200 micron blue buffer holmium fiber assembly with flat tip
• 00855430006234: 600 micron green buffer holmium fiber assembly with flat tip
• 00855430006227: 400 micron green buffer holmium fiber assembly with flat tip
• 00855430006210: 200 micron green buffer holmium fiber assembly with flat tip
• 00855430006203: 1000 micron green buffer holmium fiber assembly with flat tip
• 00855430006197: 600 micron fiber assembly with flexible cooling sheath
• 00855430006180: 600 micron thin jacket 4m fiber assembly with flat tip
• 00855430006173: 400 Micron Thin Jacket 4m fiber assembly with flat tip
• 00855430006166: Test fiber-optic, 600 micron
• 00855430006159: 800 micron holmium fiber assembly with flat tip
• 00855430006142: 600 micron holmium fiber assembly with flat tip
• 00855430006135: 400 micron holmium fiber assembly with flat tip
• 00855430006128: 200 micron holmium fiber assembly with flat tip
• 00855430006111: 1000 micron holmium fiber assembly with flat tip
• 00855430006104: 600 micron fiber assembly with side-firing cap
• 00855430006098: Test fiber-optic, 600 micron
• 00855430006081: 800 micron single-use fiber assembly with flat tip
• 00855430006074: 600 micron single-use fiber assembly with flat tip
• 00855430006067: 400 micron single-use fiber assembly with flat tip
• 00855430006050: 200 micron single-use fiber assembly with flat tip
• 00855430006043: 1000 micron single-use fiber assembly with flat tip
• 00855430006036: 800 micron single-use holmium fiber assembly with flat tip
• 00855430006029: 600 micron single-use holmium fiber assembly with flat tip
• 00855430006012: 400 micron single-use holmium fiber assembly with flat tip
• 00855430006005: 200 micron single-use holmium fiber assembly with flat tip