FDA.reportPublic FDA data

Eclipse MicroPen EVO

Primary DI
00853602008598
Brand
Eclipse MicroPen EVO
Company
ECLIPSE
Model
50EVO1000-010
Catalog number
50EVO1000-010
Device description
Eclipse MicroPen EVO handpiece which is an automated, non-surgical microneedling device designed for use by licensed healthcare practitioners or individuals directed by practitioners.
Published
2022-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K212558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203144000MicroPen EVOEclipse Medcorp, LLC2021-05-25QAI
K212558000MicroPen EVOEclipse Medcorp, LLC2021-11-24QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853602008673PackageGS11In Commercial Distribution
00853602008680PackageGS11In Commercial Distribution
00853602008598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853602008673008536020086738536020086730853602008673
00853602008680008536020086808536020086800853602008680
00853602008598008536020085988536020085980853602008598

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needling electronic handpieceA hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin (i.e., to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, hair loss) as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); the micro-needles are not part of the handpiece, however a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
969752364
Device count
1
Serial number
true

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
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
10853602008397Eclipse EVO Microneedling Cartridge50EVO2000-01050EVO2000-0102022-01-11
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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EMTDEMNPEX4906USMP06-MNP 1.5 Exceed II 2.0MT.DERM GmbHQAI2026-05-22
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B933ELSYS02R0ellacorCytrellis Biosystems, Inc.QAI2025-10-20
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04260446131102XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
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04260446131072XCELLARISPRO TWIST Control unitDermaroller GmbHQAI2025-08-26
04260446131089XCELLARISPRO TWIST HandpieceDermaroller GmbHQAI2025-08-26
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