FDA.report

10PL

Primary DI
08809709380411
Brand
10PL
Company
TENTECH Inc.
Model
10PL-Body
Device description
Powered Light based Non-Laser Surgical Instrument With Thermal Effect
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications

CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K220794000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K22079400010PLTentech Co. , Ltd.2022-11-10ONF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809709380411PrimaryGS10

GMDN Terms

TermDefinition
Intense pulsed light skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.

Sterilization Methods

Method

Regulatory Flags

DUNS number
693713346
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 DIBrandModelCatalogPublished
0880970938047310THERMA / XTHERMATIP TMET0.25-300/ XMET0.25-3002026-02-27
0880970938048010THERMA / XTHERMATIP TMET0.25-600/ XMET0.25-6002026-02-27
0880970938049710THERMA / XTHERMATIP TMFT4.0-300/ XMFT4.0-3002026-02-27
0880970938050310THERMA / XTHERMATIP TMFT4.0-600/ XMFT4.0-6002026-02-27
0880970938051010THERMA / XTHERMATIP TMFT4.0-900/ XMFT4.0-9002026-02-27
0880970938052710THERMA / XTHERMATIP TMFT5.0-300/ XMFT5.0-3002026-02-27
0880970938053410THERMA / XTHERMATIP TMFT5.0-600/ XMFT5.0-6002026-02-27
0880970938054110THERMA / XTHERMATIP TMFT5.0-900/ XMFT5.0-9002026-02-27
0880970938055810THERMA / XTHERMATIP TMBT20.0-500/ XMBT20.0-5002026-02-27
0880970938056510THERMA / XTHERMATIP TMBT20.0-1000/ XMBT20.0-10002026-02-27
0880970938034310THERMATMSY022024-06-28
0880970938035010THERMATMHP022024-06-28
0880970938043510PL10PL-H/P2024-06-28
08809709380459XTHERMAXTHERMA-Body2024-06-25
08809709380466XTHERMAXTHERMA-H/P2024-06-25

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00860009525146MediLightMEDICREATIONS LLCONF2026-02-11
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLONF2025-12-16
06974851083014BVLASERNanjing Bestview Laser S&T Co.,Ltd.ONF2024-11-27
06976573489105BilensShanghai Bele Medical Technology Co., Ltd.ONF2024-11-24
06928258000891GSDShenzhen GSD Tech Co., Ltd.ONF2024-09-30
06977620360019ZHEONEHebei Zhemai Technology Co., Ltd.ONF2024-09-19
08034108512464PRISMADEKA M.E.L.A. SRLONF2024-09-17
07290019863144Lumecca PeakINMODE M.D LTDONF2024-08-15
07290019863151Lumecca PeakINMODE M.D LTDONF2024-08-15
0880970938043510PLTENTECH Inc.ONF2024-06-28
00850062978003WORLD AESTHETIX BROAD PULSED LIGHTWORLD AESTHETIX LLCONF2024-06-25
07898961835020IPL-SqVYDENCE MEDICALONF2024-05-27
07290016633955Lumecca IINMODE M.D LTDONF2024-05-16
27290019840149Silk'nSILKN BEAUTY LTDONF2024-05-05
27290019840156Silk'nSILKN BEAUTY LTDONF2024-05-05
27290019840194Silk'nSILKN BEAUTY LTDONF2024-01-23
16976855557505Omni LaserShanghai Omni Laser Skinology Co., Ltd.ONF2024-01-01
07290110123383Iris Dye VL IPL HPALMA LASERS LTD.ONF2023-12-20
07290016681086Sheerwave PlusFORMATK SYSTEMS LTDONF2023-08-27
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07290117770214Stellar M22™ AES IPL Module KitLUMENIS BE LTDONF2023-08-02
07290117770221Stellar M22™ IPL 515nm Filter KitLUMENIS BE LTDONF2023-08-02
07290117770238Stellar M22™ IPL 560nm Filter KitLUMENIS BE LTDONF2023-08-02
07290117770245Stellar M22™ IPL 590nm Filter KitLUMENIS BE LTDONF2023-08-02
07290117770252Stellar M22™ IPL 615nm Filter KitLUMENIS BE LTDONF2023-08-02
07290117770269Stellar M22™ IPL 640nm Filter KitLUMENIS BE LTDONF2023-08-02
07290117770276Stellar M22™ IPL 695nm Filter KitLUMENIS BE LTDONF2023-08-02