Deka Smartperio

FDA UDI

Class II (US FDA UDI)

by El.en. Spa

Identity

Trade Name: DEKA SMARTPERIO FDA UDI
Generic Name: Dental solid-state laser system FDA UDI
Device Name: The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. FDA UDI
Model / Reference: M128A1 FDA UDI
Description: The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. FDA UDI

Identifiers

Catalog Number: M128A1 FDA UDI
Primary DI / UDI-DI: 08057017760528 FDA UDI
510(k) Number: K203396 FDA UDI
K213658 FDA UDI
FDA Product Code: GEX FDA UDI
NVK 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental solid-state laser system

Deka Smartperio by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: El.en. Spa

Sources (1)

FDA UDI 3b48e06b-2891-47d1-9b4c-a65b79c53daa 36 fields · synced Jun 9, 2026