510(k) · Cleared

Cleared

Reclear Phototherapy System, Model FGCM0012

K033183510(k) TraditionalCleared Apr 15, 2004197-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

Curelight, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Apr 15, 2004 as substantially equivalent to K001179 (Light Force Therapy, Inc., 2000) and 3 other predicates after a 197-day review. Its family tree reaches back 2 generations to 2000.

Decided: Apr 15, 2004
Review: 197 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K001179 (2000). 9 ancestors in all, the oldest K875052 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
1 generation backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
This deviceK033183 Reclear Phototherapy System, Model FGCM0012Curelight, Ltd. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K001179	Super Nova, Acubeam	Light Force Therapy, Inc.	2000	—
−1	K020017	Medx 1000 Series	Medx Electronics, Inc.	2002	—
0 (this device)	K033183	Reclear Phototherapy System, Model FGCM0012	Curelight, Ltd.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1989	1	0
1996	1	0
1999	1	0
2001	1	0
2002	1	0
2003	1	0

FIG. 1 — Lineage of K033183, 2000–2004Source: 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? (4)

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
*	K001179	Super Nova, Acubeam Summary page 1 …Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Predicate Devices Light Force Therapy's SuperNova/Acubeam (K001179), MedX Health \\\PH - 89075/0001 - 13464 vl Corp. 's MedX 1000 series (K 020017), C&H international Inc.'s TD…	Light Force Therapy, Inc.	2000	—
*	K020017	Medx 1000 Series Summary page 2 …redicate Devices Light Force Therapy's SuperNova/Acubeam (K001179), MedX Health \\\PH - 89075/0001 - 13464 vl Corp. 's MedX 1000 series (K 020017), C&H international Inc.'s TDP lamp (K020851), and Curelight's iClear Phototherapy System (K030338). Intended Use The ReClear…	Medx Electronics, Inc.	2002	—
*	K020851	TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… Summary page 2 …apy's SuperNova/Acubeam (K001179), MedX Health \\\PH - 89075/0001 - 13464 vl Corp. 's MedX 1000 series (K 020017), C&H international Inc.'s TDP lamp (K020851), and Curelight's iClear Phototherapy System (K030338). Intended Use The ReClear TM Phototherapy System ("ReClearT M "1) is i…	C&H International	2002	—
*	K030338	Iclear Phototherapy System, Model FGCM0002 Summary page 2 …PH - 89075/0001 - 13464 vl Corp. 's MedX 1000 series (K 020017), C&H international Inc.'s TDP lamp (K020851), and Curelight's iClear Phototherapy System (K030338). Intended Use The ReClear TM Phototherapy System ("ReClearT M "1) is intended to provide phototherapeutic light to the body.…	Curelight, Ltd.	2003	—

Also cleared against K001179: 12 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
None of the 9 ancestors has a recall.
12 other devices also cite its predicate K001179.

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.

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 ReClearTrm Phototherapy System ("ReClearTM ") is intended to provide phototherapeutic light to the body. The ReClearTM is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and IR light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033183 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033183: Reclear Phototherapy System, Model FGCM0012.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033183

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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