FDA.reportPublic FDA data

deepLive

Primary DI
03775000102715
Brand
deepLive
Company
DAMAE MEDICAL
Model
OSP12
Device description
deepLive is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing three-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.
Published
2025-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240610000deepLiveDamae Medical2024-07-09NQQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03775000102715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03775000102715037750001027153775000102715

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological optical coherence tomography systemAn assembly of devices designed to use a broad-bandwidth light beam aimed via an applicator at a region of interest (ROI) on the surface of the skin for optical coherence tomography (OCT) to provide high-resolution images (e.g., above 1 micron) of the surface tissue in order to visualize skin morphology. It typically consists of a main unit with an operator's console, a computer for image storage, a hand-held or electromechanical probe (applicator), and a visual display unit (VDU). Reflected light is picked up by the probe that converts it into electrical signals. The computer and dedicated software provide cross-sectional images of the derma or two- or three-dimensional (3-D) volume scans.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
266469174
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067054920Ultreon™LIGHTLAB IMAGING, INC.NQQ2026-05-19
00812763011007OPUSWAVETerumo Cardiovascular Systems CorporationNQQ2026-05-13
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183865PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06971141530494Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
06971141530500Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
05415067053879ILUMIEN™ OPTIS™ to OPTIS™LIGHTLAB IMAGING, INC.NQQ2025-07-31
05415067047694Ultreon™LIGHTLAB IMAGING, INC.NQQ2024-03-29
00860008045508Starlight Imaging CatheterSpectrawave, Inc.NQQ2024-02-23
00860008045515HyperVue Imaging SystemSpectrawave, Inc.NQQ2024-02-23
00851354004509Lightbox L3AVINGER, INC.NQQ2024-01-29
05415067048882AptiVue™LIGHTLAB IMAGING, INC.NQQ2023-09-29
06932503570022Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570039Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570046Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570053Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570060Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570077Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570084Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570091Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570107Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570029MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570036MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570043MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570050MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570067MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570074MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570081MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11