FDA.reportPublic FDA data

Eclipse EVO Microneedling Cartridge

Primary DI
10853602008397
Brand
Eclipse EVO Microneedling Cartridge
Company
ECLIPSE
Model
50EVO2000-010
Catalog number
50EVO2000-010
Device description
MicroPen EVO Turbo Safety Cartridge (Each). Cartridges are sterilized and packaged individually for single patient use.
Published
2022-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QAIPowered Microneedle Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAIPowered Microneedle DeviceGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203144000MicroPen EVOEclipse Medcorp, LLC2021-05-25QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853602008397PackageGS112In Commercial Distribution
00853602008390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085360200839710853602008397
00853602008390008536020083908536020083900853602008390

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needling electronic handpiece cartridgeA device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-759-6876info@eclipsemed.com

Regulatory Flags#

DUNS number
969752364
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00853602008185Eclipse MicroPen EliteMP1001-IISilverMP1001-IISilver2018-10-04
00853602008390Eclipse EVO Microneedling Cartridge50EVO2000-01050EVO2000-0102022-01-11
00853602008598Eclipse MicroPen EVO50EVO1000-01050EVO1000-0102022-01-11
00853602008406Eclipse MicroPen Elite Turbo Safety CartridgeMPE1002MS-KitMPE1002MS-Kit2019-05-03
00853602008192Eclipse Cosmetic Applicator KitMP1002-CA-K12GFMP1002-CA-K12GF2018-10-04
00853602008208Eclipse Cosmetic Applicator KitMP1002-CA-K12HAMP1002-CA-K12HA2018-10-04
00853602008215Eclipse Cosmetic Applicator KitMP1002-CA-K1GFMP1002-CA-K1GF2018-10-04
00853602008222Eclipse Cosmetic Applicator KitMP1002-CA-K1HAMP1002-CA-K1HA2018-10-04
00853602008239Eclipse MicroPen EliteMP1002-II-K18CANMP1002-II-K18CAN2018-10-04
00853602008246Eclipse Cosmetic Applicator KitCA-100-00-01CA-100-00-012018-10-04
00853602008253Eclipse Cosmetic Applicator KitCA-100-00-02CA-100-00-022018-10-04
00853602008260Eclipse Cosmetic Applicator KitMP1002-CA-K12GF-SMP1002-CA-K12GF-S2018-10-04
00853602008338Eclipse MicroPen EliteMP1002-II-K12HAMP1002-II-K12HA2018-10-04
00853602008345Eclipse MicroPen EliteMP1002-II-K12GFMP1002-II-K12GF2018-10-04
00853602008352Eclipse MicroPen EliteMP1002-II-12MP1002-II-122018-10-04
00853602008369Eclipse MicroPen EliteMP1002-II-K12MP1002-II-K122018-10-04
00853602008376Eclipse MicroPen EliteMP1002-CA-K12HA-SMP1002-CA-K12HA-S2018-10-04
00853602008604Eclipse Hypodermic Needle - 18G50PRP2500-N18gx25mm2022-01-11
00853602008611Eclipse Hypodermic Needle - 30G50PRP2500-N30gx13mm50PRP2500-N30gx13mm2022-01-11
00853602008079Eclipse PRP HC PRP2000PRP20002018-10-04

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04260446131072XCELLARISPRO TWIST Control unitDermaroller GmbHQAI2025-08-26
04260446131089XCELLARISPRO TWIST HandpieceDermaroller GmbHQAI2025-08-26
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