FDA.reportPublic FDA data

Apolomed

Primary DI
06970745917700
Brand
Apolomed
Company
Shanghai Apolo Medical Technology Co.,Ltd
Model
HS-770
Device description
Phototherapy Systems
Published
2020-01-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190938000Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.2019-06-26GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970745917700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970745917700069707459177006970745917700

GMDN Terms#

Term, Definition table
TermDefinition
Skin photodynamic therapy/phototherapy lampA portable, mains electricity (AC-powered) lamp intended to emit low-level narrow-band (LLNB) red light (e.g., 600-650nm) and blue light (e.g., 415-440nm) either separately or simultaneously for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as actinic keratosis and non-melanoma skin cancer, and for phototherapy applications (through modification of skin metabolism) to treat skin complaints such as acne, rosacea and sun spots. It uses light-emitting diodes (LEDs) to produce a heatless light source which may be used for treatment at multiple anatomical sites. It is intended to be used by a healthcare professional in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529854247
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970745918516ApolomedHS-8512021-03-26
06970745912323ApolomedHS-2322025-07-21
06970745912330ApolomedHS-2332025-07-21
06970745915911ApolomedHS-5912024-04-30
06970745912309ApolomedHS-2302022-11-30
06970745919001ApolomedHS-900K2022-02-17
06970745914112ApolomedHS-4112020-07-22
06970745914129ApolomedHS-411A2020-07-22
06970745912989ApolomedHS-298K2020-07-21
06970745913016ApolomedHS-300CK2020-07-21
06970745913108ApolomedHS-310K2020-07-21
06970745916208ApolomedHS-620K2020-07-21
06970745916512ApolomedHS-650K2020-07-21
06970745916604ApolomedHS-660K2020-07-21
06970745918103ApolomedHS-810N2020-07-21
06970745918110ApolomedHS-811N2020-07-21
06970745918127ApolomedHS-812N2020-07-21
06970745918165ApolomedHS-8162020-07-21
06970745918172ApolomedHS-8172020-07-21
06970745918189ApolomedHS-8182020-07-21

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