Ellacor
12 pack Consumable Kit (Triple Needle Cartridge,V2) includes the following items: Needle Cartridge (EL-03N02) Biofilter Suction Tube Cleaning Cover (EL-CCV01) Tube Clip (EL-CLP01)
10manufacturers in China registered for this device type
25catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Beijing (4), Guangdong (4), Hebei (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Beijing Perfectlaser Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 12 |
| Hebei Lufen Tech Co., Limited | Xingtai | Hebei | Contract manufacturer | 12 |
| Sanhe Jumei Technology Co., Ltd. | Sanhe | Hebei | Manufacturer | 12 |
| Guangzhou Ekai Electronic Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Guangdong Carain Beauty Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Cytrellis Biosystems, Inc., United States |
|---|---|
| FDA product code | QAI |
| Device type | Powered Microneedle Device |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4430 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K202517 |
| Record published | 2024-01-03 |
| Record revised | 2025-03-27 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| EL-CON02 | In distribution | ||
| EL-SYS02 | In distribution | ||
| EL-FTS01 | In distribution | ||
| EL-KIT03 | In distribution | ||
| EL-03N02 | In distribution | ||
| EL-FTS01-R | In distribution | ||
| EL-CON02-R | In distribution | ||
| EL-CON01 | In distribution | ||
| EL-KIT01 | In distribution | ||
| EL-HPC02-R | In distribution | ||
| EL-03N01 | In distribution | ||
| EL-KIT02 | In distribution | ||
| EL-KIT04 | In distribution | ||
| EL-03N01 | 2 | In distribution | |
| EL-SYS02-R | In distribution | ||
| EL-03N02 | 2 | In distribution | |
| EL-CLP01 | 6 | In distribution | |
| EL-03N02 | In distribution | ||
| EL-CCV01 | 2 | In distribution | |
| EL-HPC01-R | In distribution | ||
| EL-CCV01 | 6 | In distribution | |
| EL-CON01-R | In distribution | ||
| EL-HPC01 | In distribution | ||
| EL-HPC02 | In distribution | ||
| EL-SYS01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Collagen P.I.N. | Induction Therapies, LLC | 9 |
| Footswitch | Mt.derm GmbH | 5 |
| SkinPen Precision Elite | Bellus Medical, LLC | 4 |
| Exceed | Mt.derm GmbH | 4 |
| Safety Needle Cartridge 6-MNP 1.5 Exceed US | Mt.derm GmbH | 3 |
| SkinPen Precision Treatment Kits | Bellus Medical, LLC | 3 |
| CytoPen S2 | Emage Medical, LLC | 3 |
| Dp4 | Equipmed USA B.V. | 3 |
| PRO Pen Microneedling System | Dermalogica, LLC | 1 |
| Xcellarispro Twist Control unit | Dermaroller GmbH | 1 |
| Eclipse EVO Microneedling Cartridge | Eclipse, Inc. | 1 |
| Eclipse MicroPen EVO | Eclipse, Inc. | 1 |
Showing 12 of 43. All products under Powered Microneedle Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252752 | 2025-10-30 |
| K202517 | 2021-07-09 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cytrellis Biosystems, Inc. | 510(k) number | 2023-06-23 | Class II | Process control | Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and i | 127 systems |
| Cytrellis Biosystems, Inc. | 510(k) number | 2023-04-07 | Class II | Use error | Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, and/or scarring. | 89 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.