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Alex 755 Delivery System Demo

FDA UDI

Class II (US FDA UDI)

by Candela Corporation

Identity

Trade Name
Alex 755 Delivery System Demo FDA UDI
Generic Name
Dermatological laser beam guiding handpiece FDA UDI
Device Name
Delivery System Assembly FDA UDI
Model / Reference
0800-00-1093 FDA UDI
Description
Delivery System Assembly FDA UDI

Identifiers

Primary DI / UDI-DI
00817495022123 FDA UDI
510(k) Number
K081324 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Dermatological laser beam guiding handpiece 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

Alex 755 Delivery System Demo by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K081324 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 fc52603c-b836-4da3-8cac-1bf5aab6975d 35 fields · synced Jun 8, 2026