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Sh1

FDA UDI

Class II (US FDA UDI)

by El.en. Spa

Identity

Trade Name
SH1 FDA UDI
Generic Name
Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Device Name
The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG laser sources. FDA UDI
Model / Reference
M077H3 FDA UDI
Description
The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG laser sources. FDA UDI

Identifiers

Catalog Number
M077H3 FDA UDI
Primary DI / UDI-DI
08057017760207 FDA UDI
510(k) Number
K122125 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 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

Category: Musculoskeletal infrared phototherapy unit, non-wearable

Sh1 by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Musculoskeletal infrared phototherapy unit, non-wearable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
El.en. Spa

Sources (1)

  • FDA UDI 14a2fb95-20e5-4ab8-bb89-e27e45cb0a2b 36 fields · synced Jun 9, 2026