FDA.reportPublic FDA data

Apolomed

Primary DI
06970745918516
Brand
Apolomed
Company
Shanghai Apolo Medical Technology Co.,Ltd
Model
HS-851
Device description
Diode Laser Body Sculpture System
Published
2021-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKTLaser For Disruption Of Adipocyte Cells For Aesthetic UseGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201731000Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.2020-09-10PKT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970745918516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970745918516069707459185166970745918516

GMDN Terms#

Term, Definition table
TermDefinition
Low-intensity laser fat liquefaction systemAn assembly of devices designed for the noninvasive application of low-level laser energy [low-level laser therapy (LLLT)] to liquefy (emulsify) subcutaneous and visceral adipose tissue (fat) for cosmetic/aesthetic (e.g., body contouring, circumference reduction) and medical (e.g. weight-loss, lipid reduction) applications. It is a mains electricity (AC-powered) system, mobile on wheels, which incorporates laser diode modules on adjustable arms, a control monitor, and software. It is an independent, primary device which may be used as an adjunct modality in conjunction with liposuction and surgical techniques as a secondary function.

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
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
06970745918196ApolomedHS-8192020-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057017760689DEKA PHYSIQ 360DEKA M.E.L.A. SRLPKT2023-10-11
00810060830444Venus BlissVenus Concept Inc.PKT2023-06-08
00810060830987Venus Bliss MaxVenus Concept Inc.PKT2023-06-08
07290016541281BLISS SYSTEMVENUS CONCEPT LTDPKT2021-07-14
07290016541632BLISS SYSTEMVENUS CONCEPT LTDPKT2021-07-14
07290016541564BODY LASER APPLICATOR SERVICE PACK, BlissVENUS CONCEPT LTDPKT2021-07-14
07290016541618(MP)2 APPLICATOR BLISSVENUS CONCEPT LTDPKT2021-07-14
07290016541625BODY LASER APPLICATOR BLISSVENUS CONCEPT LTDPKT2021-07-14
07290016541717(MP)2 APPLICATOR SERVICE PACK, BlissVENUS CONCEPT LTDPKT2021-07-14
07290016541724Belt BlissVENUS CONCEPT LTDPKT2021-07-14
00841494107925ASSY, MASK, Petite, Submental AdapterCynosure, LLCPKT2019-09-18
00841494107994RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLYCynosure, LLCPKT2018-01-18
00841494107956ASSY, FINAL LASER, SCULPSURE, SUB ONLYCynosure, LLCPKT2017-11-29
00841494107963ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZILCynosure, LLCPKT2017-11-29
00841494107468ASSY, MASK FLEX CIRCUIT, MED, SUBCynosure, LLCPKT2017-09-26
00841494100032SculpSure laser assemblyCynosure, LLCPKT2017-07-26
00841494100049SculpSure ApplicatorCynosure, LLCPKT2017-07-26
00841494106867SculpSure Applicator, RefurbishedCynosure, LLCPKT2017-07-24
00841494106775SculpSure, Laser Assembly, BrazilCynosure, LLCPKT2017-07-24