510(k) · Cleared

Cleared

Quasar Blue Light Therapy System

K072767510(k) TraditionalCleared Oct 15, 200717-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

Silver Bay, LLC · GEX Powered Laser Surgical Instrument

Cleared on Oct 15, 2007 after a 17-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 131 later devices descend from it.

Decided: Oct 15, 2007
Review: 17 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

131 later devices descend from it, 1 citing it directly.

This deviceK072767 Quasar Blue Light Therapy SystemSilver Bay, LLC · 2007
Descendant · cites it directly · 130 of its ownK093963 Quasar Blue Light Therapy SystemSilver Bay, LLC · 2010
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 ownK111286 Quasar CalypsoSilver Bay, LLC · 2012
Descendant · 3 generations on · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017

Showing 5 of 131 descendants. See all descendants

Descendants cleared per year

2010high 41 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 131 · See all

K093963Quasar Blue Light Therapy SystemSilver Bay, LLC · 2010 · cites it directly130descendants
K121435Silkn BlueHome Skinovations, Ltd. · 2013 · 2 generations on125descendants
K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014 · 2 generations on81descendants
K111286Quasar CalypsoSilver Bay, LLC · 2012 · 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
0 (this device)	K072767	Quasar Blue Light Therapy System	Silver Bay, LLC	2007	—
+1	K093963	Quasar Blue Light Therapy System	Silver Bay, LLC	2010	—
+2	K121435	Silkn Blue	Home Skinovations, Ltd.	2013	—
+2	K131461	Lightstim for Acne/ Lightstim for Acne Mini	Led Intellectual Properties, LLC	2014	—
+2	K111286	Quasar Calypso	Silver Bay, LLC	2012	—
+3	K162098	LED Phototherapy Device	Li-Tek Electronic Technology Corporation	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2013	1	0
2014	2	0
2015	4	0
2016	4	0
2017	3	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 K072767, 2007–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (131)

See all 131

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093963	Quasar Blue Light Therapy System	Silver Bay, LLC	2010	130

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?

Of its descendants, K093963 (Silver Bay, LLC, 2010) has gone furthest, with 130 descendants of its own.

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 Quasar Blue Light Therapy System is intended to provide photo therapeutic light to the body. The Quasar Blue Light Therapy System is generally indicated to treat dermatological conditions. The Quasar Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K072767 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072767: Quasar Blue Light Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072767

Report an extraction error

Are you the manufacturer?

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