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TrueSpot™ 2.0mm Handpiece

FDA UDI

Class II (US FDA UDI)

by Lumenis Be, Inc.

Identity

Trade Name
TrueSpot™ 2.0mm Handpiece FDA UDI
Generic Name
Surgical laser system beam-focus handpiece FDA UDI
Model / Reference
NA FDA UDI

Identifiers

Primary DI / UDI-DI
07290117771679 FDA UDI
510(k) Number
K030147 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Surgical laser system beam-focus handpiece 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical laser system beam-focus handpiece

TrueSpot™ 2.0mm Handpiece by Lumenis Be, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical laser system beam-focus handpiece.

Cleared under the same submission

K030147 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lumenis Be, Inc.

Sources (1)

  • FDA UDI a2cdc8d0-92c9-4778-8abf-8cc3239d5bfb 33 fields · synced Jun 8, 2026