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Waterlase iPlus Dental Laser System
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K210183
Identity
- Trade Name
- Waterlase iPlus Dental Laser System FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
- Model / Reference
- 7200854-02 Refurbished FDA UDI
- Description
- An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00647529002353 FDA UDI
- 510(k) Number
- K101658 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental solid-state laser system
Waterlase iPlus Dental Laser System by Biolase, Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Dental solid-state laser system.
- TIP for LITETOUCH — Light Instruments · Class II
- TIP for LITETOUCH — Light Instruments · Class II
- E1 Handpiece, LT — Light Instruments · Class II
- InPulse Dental Laser — Beyond International Inc. · Class II
- Straight Handpiece, LT — Light Instruments · Class II
- EdgePRO™ — US Endodontics, LLC · Class II
- TIP for LITETOUCH — Light Instruments · Class II
- DEKA SMARTPERIO — EL.EN. SPA · Class II
Cleared under the same submission
K101658 also covers:
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210183 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biolase, Inc.
Sources (2)
- FDA UDI e9c1bf5a-81cb-4240-a59b-42856ff9e33e 60 fields · synced Jun 18, 2026
- FDA 510(k) K210183 1 fields · synced May 25, 2026