510(k) · Cleared

Cleared

Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001

K070185510(k) TraditionalCleared Aug 21, 2007214-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pharos Life Corporation · GEX Powered Laser Surgical Instrument

Cleared on Aug 21, 2007 as substantially equivalent to K031805 (Dusa Pharmaceuticals, Inc., 2003) after a 214-day review. Its family tree reaches back 1 generation to 2003. 139 later devices descend from it.

Decided: Aug 21, 2007
Review: 214 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K031805 (2003). 139 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK031805 Blu-U, Model 4170Dusa Pharmaceuticals, Inc. · 2003
This deviceK070185 Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red…Pharos Life Corporation · 2007
Descendant · cites it directly · 137 of its ownK080591 Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008
Descendant · 2 generations on · 125 of its ownK121435 Silkn BlueHome Skinovations, Ltd. · 2013
Descendant · 2 generations on · 81 of its ownK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
Descendant · 2 generations on · 76 of its ownK124042 Tanda Mini Skincare SystemSyneron Beauty · 2013
Descendant · 3 generations on · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017

Showing 5 of 139 descendants. See all descendants

Descendants cleared per year

2008high 41 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 139 · See all

K080591Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008 · cites it directly137descendants
K121435Silkn BlueHome Skinovations, Ltd. · 2013 · 2 generations on125descendants
K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014 · 2 generations on81descendants
K124042Tanda Mini Skincare SystemSyneron Beauty · 2013 · 2 generations on76descendants
K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · 3 generations on75descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K031805	Blu-U, Model 4170	Dusa Pharmaceuticals, Inc.	2003	—
0 (this device)	K070185	Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001	Pharos Life Corporation	2007	—
+1	K080591	Tanda Skincare System, Model: Ptscs	Pharos Life Corporation	2008	—
+2	K121435	Silkn Blue	Home Skinovations, Ltd.	2013	—
+2	K131461	Lightstim for Acne/ Lightstim for Acne Mini	Led Intellectual Properties, LLC	2014	—
+2	K124042	Tanda Mini Skincare System	Syneron Beauty	2013	—
+3	K162098	LED Phototherapy Device	Li-Tek Electronic Technology Corporation	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2010	3	0
2013	2	0
2014	2	0
2015	5	0
2016	6	0
2017	4	0
2018	6	0
2019	3	0
2020	1	0
2021	8	0
2022	10	0
2023	12	0
2024	14	0
2025	41	0
2026	20	0

FIG. 1 — Lineage of K070185, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K031805	Blu-U, Model 4170 Summary page 1 …5. Substantial Equivalence: The Tinda Skincare System is substantially similar to: BLU-U, MODEL 4170, DUSA PHARMACEUTICALS, INC K031805 (Sep 9, 2003) 1/2 6. Device Description: The Thnda Skincare Syste…	Dusa Pharmaceuticals, Inc.	2003	—

Also cleared against K031805: 5 other devices →

What descends from it? (139)

See all 139

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080591	Tanda Skincare System, Model: Ptscs	Pharos Life Corporation	2008	137
K082232	Evis MD Plantium Blue	Ageless Beauty Corporation	2008	3

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K080591 (Pharos Life Corporation, 2008) has gone furthest, with 137 descendants of its own.
5 other devices also cite its predicate K031805.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

The tinda Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070185 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070185: Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070185

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026