DEVICE: Waterlase Express All-Tissue Laser System (00647529002339)

Device Identifier (DI) Information

Waterlase Express All-Tissue Laser System
7210001
Not in Commercial Distribution
7210001
Biolase, Inc.
00647529002339
GS1
June 27, 2017
1
152165700 *Terms of Use
An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, and a wireless foot-switch. Other system components include protective eyewear, power cords, tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47880 Dental solid-state laser system
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K161669 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 45 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f26bd105-8d74-4434-b67e-ed3ae72237ec
June 12, 2023
5
February 23, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
1-800-321-6717
Waterlaseservice@biolase.com
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