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
OTC
false
Sterile
false
Single use
false

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Regulatory Flags#

DUNS number
529854247
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970745912927ApolomedHS-2902026-08-17
06970745912934ApolomedHS-290E2026-08-17
06970745912996ApolomedHS-2982026-08-17
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

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