SculpSure laser assembly
- Primary DI
- 00841494100032
- Brand
- SculpSure laser assembly
- Company
- Cynosure, LLC
- Model
- 100-7026-010
- Device description
- SculpSure laser assembly
- Published
- 2017-07-26
- 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| Code | Name |
|---|
| PKT | Laser for disruption of adipocyte cells for aesthetic use |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | General, Plastic Surgery | 2 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00841494100032 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
Source identifier, GTIN-14 normalized, UPC-A table| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00841494100032 | 00841494100032 | 841494100032 | 0841494100032 |
Regulatory Flags#
- DUNS number
- 780318028
- 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
- true
- Expiration date on label
- false
- 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 DI | Brand | Model | Catalog | Published |
|---|
| 00841494100049 | SculpSure Applicator | 100-7026-100 | | 2017-07-26 |
| 00841494106867 | SculpSure Applicator, Refurbished | R100-7026-100 | | 2017-07-24 |
| 00841494107468 | ASSY, MASK FLEX CIRCUIT, MED, SUB | 100-7026-816 | | 2017-09-26 |
| 00841494107956 | ASSY, FINAL LASER, SCULPSURE, SUB ONLY | 100-7026-910 | | 2017-11-29 |
| 00841494107963 | ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL | 100-7026-920 | | 2017-11-29 |
| 00841494107994 | RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLY | R100-7026-910 | | 2018-01-18 |
| 00841494100025 | Focus Cap Array | 100-7012-055 | | 2016-09-24 |
| 00841494100001 | PicoSure | 100-7012-010 | | 2016-09-24 |
| 00841494100056 | Elite MPX | 100-7009-010 | | 2016-09-24 |
| 00841494100063 | Elite+ | 100-7018-010 | | 2016-09-24 |
| 00841494100070 | Apogee+ | 100-7018-290 | | 2016-09-24 |
| 00841494100100 | Accolade | 100-7008-010 | | 2016-09-24 |
| 00841494100551 | Spacer tip, handpiece | 130-7012-324 | | 2016-09-24 |
| 00841494100568 | Spacer tip for 532 Handpiece | 130-7012-490 | | 2016-09-24 |
| 00841494103354 | 532 Lite Handpiece | 659-0644 | | 2016-09-24 |
| 00841494103583 | PicoSure 1064 nm Handpiece | 100-7012-079 | | 2016-09-24 |
| 00841494103590 | PicoSure 532 nm Handpiece | 100-7012-076 | | 2016-09-24 |
| 00841494103675 | Elite+ / Elite MPX Treatment Tip | 100-7018-100 | | 2016-09-24 |
| 00841494106775 | SculpSure, Laser Assembly, Brazil | 100-7026-020 | | 2017-07-24 |
| 00841494106980 | PicoSure 532 Delivery System | 100-7012-532 | | 2017-07-24 |
Other Devices Sharing Product Codes#
Primary DI, Brand, Company table| Primary DI | Brand | Company | Product code | Published |
|---|
| 08057017760689 | DEKA PHYSIQ 360 | DEKA M.E.L.A. SRL | PKT | 2023-10-11 |
| 00810060830444 | Venus Bliss | Venus Concept Inc. | PKT | 2023-06-08 |
| 00810060830987 | Venus Bliss Max | Venus Concept Inc. | PKT | 2023-06-08 |
| 07290016541281 | BLISS SYSTEM | VENUS CONCEPT LTD | PKT | 2021-07-14 |
| 07290016541632 | BLISS SYSTEM | VENUS CONCEPT LTD | PKT | 2021-07-14 |
| 07290016541564 | BODY LASER APPLICATOR SERVICE PACK, Bliss | VENUS CONCEPT LTD | PKT | 2021-07-14 |
| 07290016541618 | (MP)2 APPLICATOR BLISS | VENUS CONCEPT LTD | PKT | 2021-07-14 |
| 07290016541625 | BODY LASER APPLICATOR BLISS | VENUS CONCEPT LTD | PKT | 2021-07-14 |
| 07290016541717 | (MP)2 APPLICATOR SERVICE PACK, Bliss | VENUS CONCEPT LTD | PKT | 2021-07-14 |
| 07290016541724 | Belt Bliss | VENUS CONCEPT LTD | PKT | 2021-07-14 |
| 06970745918516 | Apolomed | Shanghai Apolo Medical Technology Co.,Ltd | PKT | 2021-03-26 |
| 00841494107925 | ASSY, MASK, Petite, Submental Adapter | Cynosure, LLC | PKT | 2019-09-18 |
| 00841494107994 | RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLY | Cynosure, LLC | PKT | 2018-01-18 |
| 00841494107956 | ASSY, FINAL LASER, SCULPSURE, SUB ONLY | Cynosure, LLC | PKT | 2017-11-29 |
| 00841494107963 | ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL | Cynosure, LLC | PKT | 2017-11-29 |
| 00841494107468 | ASSY, MASK FLEX CIRCUIT, MED, SUB | Cynosure, LLC | PKT | 2017-09-26 |
| 00841494100049 | SculpSure Applicator | Cynosure, LLC | PKT | 2017-07-26 |
| 00841494106867 | SculpSure Applicator, Refurbished | Cynosure, LLC | PKT | 2017-07-24 |
| 00841494106775 | SculpSure, Laser Assembly, Brazil | Cynosure, LLC | PKT | 2017-07-24 |