510(k) · Cleared

Cleared

Revlite Q-Switched ND:Yag Laser

K063112510(k) SpecialCleared Dec 1, 200651-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

Hoya Conbio, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Dec 1, 2006 as substantially equivalent to K014234 (Continuum Electro-Optics, Inc., 2002) after a 51-day review. Its family tree reaches back 1 generation to 2002. 169 later devices descend from it.

Decided: Dec 1, 2006
Review: 51 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K014234 (2002). 169 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK014234 Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6…Continuum Electro-Optics, Inc. · 2002
This deviceK063112 Revlite Q-Switched ND:Yag LaserHoya Conbio, Inc. · 2006
Descendant · cites it directly · 168 of its ownK063834 Revlite C6 Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2007
Descendant · 2 generations on · 166 of its ownK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
Descendant · 3 generations on · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
Descendant · 4 generations on · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
Descendant · 3 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015

Showing 5 of 169 descendants. See all descendants

Descendants cleared per year

2007high 26 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 169 · See all

K063834Revlite C6 Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2007 · cites it directly168descendants
K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009 · 2 generations on166descendants
K103455Spectra Laser SystemLutronic Corporation · 2011 · 3 generations on92descendants
K113588Spectra Laser SystemLutronic Corporation · 2012 · 4 generations on82descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 3 generations on62descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K014234	Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND…	Continuum Electro-Optics, Inc.	2002	—
0 (this device)	K063112	Revlite Q-Switched ND:Yag Laser	Hoya Conbio, Inc.	2006	—
+1	K063834	Revlite C6 Q-Switched ND:Yag Laser System	Hoya Conbio, Inc.	2007	—
+2	K083889	Fotona QX ND:Yag/KTP Laser System Family	Fotona D.D.	2009	—
+3	K103455	Spectra Laser System	Lutronic Corporation	2011	—
+4	K113588	Spectra Laser System	Lutronic Corporation	2012	—
+3	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0
2011	1	0
2012	2	0
2013	2	0
2014	4	0
2015	3	0
2016	9	0
2017	11	0
2018	10	0
2019	6	0
2020	10	0
2021	12	0
2022	20	0
2023	13	0
2024	20	0
2025	26	0
2026	18	0

FIG. 1 — Lineage of K063112, 2002–2026Source: 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? (2)

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
*	K014234	Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser Summary page 1 …Lase 1064 2 Joule Laser System - K Unknown MedLite C6 Q-Switched Nd: YAG Laser System - K014234 Device Description: The RevLite System laser unit and controls are contained in a…	Continuum Electro-Optics, Inc.	2002	—
*	—	Focus Medical NaturaLase 1064 2 Joule Laser System Named without a submission number			—

Also cleared against K014234: 13 other devices →

What descends from it? (169)

See all 169

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

Number	Device	Applicant	Decided	Descendants
K063834	Revlite C6 Q-Switched ND:Yag Laser System	Hoya Conbio, Inc.	2007	168

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, K063834 (Hoya Conbio, Inc., 2007) has gone furthest, with 168 descendants of its own.
13 other devices also cite its predicate K014234.

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 RevLite Q-Switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Specific Indications: 1064 nm wavelength: Tattoo Removal: Dark Ink: (Black & Blue) Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation. Skin resurfacing procedures for the treatment of acne scars and…

Read the full statement (152 words)

Specific Indications:

1064 nm wavelength:

Tattoo Removal: Dark Ink: (Black & Blue)

Nevus of Ota

Removal or lightening of unwanted hair with or without adjuvant preparation.

Skin resurfacing procedures for the treatment of acne scars and wrinkles

532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece):

Tattoo Removal: Light Ink (Red, Sky Blue, Green)

Treatment of Vascular Lesions including, but not limited to:

* port wine birthmarks

* telangiectasias

* spider angioma

* cherry angioma

spider nevi

Treatment of Pigmented Lesions including, but not limited to:

* cafe-au-lait birthmarks

* solar lentiginos

* senile lentiginos

* Becker's nevi

* Freckles

* Nevus spilus

Skin resurfacing procedures for the treatment of acne scars and wrinkles

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063112 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063112: Revlite Q-Switched ND:Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063112

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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