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GentleLase Pro Limited Edition

FDA UDI

Class II (US FDA UDI)

by Candela Corporation

Identity

Trade Name
GentleLase Pro Limited Edition FDA UDI
Generic Name
Dermatological solid-state laser system FDA UDI
Device Name
Pulsed Laser FDA UDI
Model / Reference
9914-16-9040 FDA UDI
Description
Pulsed Laser FDA UDI

Identifiers

Primary DI / UDI-DI
00817495021003 FDA UDI
510(k) Number
K140732 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Dermatological solid-state laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
Not 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

GentleLase Pro Limited Edition by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K140732 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Candela Corporation

Sources (1)

  • FDA UDI d5cb074c-1e8b-4630-bc63-db986d674637 36 fields · synced Jun 8, 2026