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Apolomed

FDA UDI

Class II (US FDA UDI)

by Shanghai Apolo Medical Technology Co., Ltd

Identity

Trade Name
Apolomed FDA UDI
Generic Name
Intense pulsed light skin surface treatment system FDA UDI
Device Name
IPL (Intense Pulsed Light) Treatment Systems FDA UDI
Model / Reference
HS-300CK FDA UDI
Description
IPL (Intense Pulsed Light) Treatment Systems FDA UDI

Identifiers

Primary DI / UDI-DI
06970745913016 FDA UDI
510(k) Number
K200746 FDA UDI
FDA Product Code
ONF FDA UDI
GMDN Term
Intense pulsed light skin surface treatment 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intense pulsed light skin surface treatment system

Apolomed by Shanghai Apolo Medical Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intense pulsed light skin surface treatment system.

Cleared under the same submission

K200746 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shanghai Apolo Medical Technology Co., Ltd

Sources (1)

  • FDA UDI 51fd9165-4860-4327-8b48-23c5a015d50b 35 fields · synced May 30, 2026