Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Quanta System Spa — Predicate Candidate Screening

57 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

72 daysmedian FDA review time

154 days90th percentile

57clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K240983	Discovery Pico; Discovery Pico Plus; Discovery Pico Derm	Quanta System Spa	2025-06-06	422	0
K243588	Single Use CO2 Laser Fiber (HAF005001)	Quanta System Spa	2025-02-19	91	0
K241092	Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT	Quanta System Spa	2024-10-10	171	0
K242251	Litho 60; Litho 100; Litho 150	Quanta System Spa	2024-09-03	34	0
K232236	Echo	Quanta System Spa	2023-10-20	85	0
K223404	Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Sup	Quanta System Spa	2023-01-20	72	0
K220426	Fiber Dust PRO	Quanta System Spa	2022-03-16	30	0
K211228	Rosso	Quanta System Spa	2022-02-02	285	0
K210142	Fiber Dust	Quanta System Spa	2021-03-11	51	0
K202503	Chrome	Quanta System Spa	2020-11-18	79	0
K202041	Opera Evo	Quanta System Spa	2020-10-15	84	0
K201455	Litho 150, Cyber Ho 150	Quanta System Spa	2020-06-30	29	0
K200234	Surgical laser fibers	Quanta System Spa	2020-02-25	26	0
K192600	Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60	Quanta System Spa	2020-02-21	154	0
K192990	Litho Evo	Quanta System Spa	2019-12-20	56	0
K191842	Discovery Pico, Discovery Pico Plus, Discovery Pico Derm	Quanta System Spa	2019-09-17	70	0
K192160	EVO Platform	Quanta System Spa	2019-09-06	28	0
K182669	Youlaser CO2	Quanta System Spa	2018-10-17	22	0
K181632	Venacure 1470 Pro	Quanta System Spa	2018-09-17	89	0
K180922	Empower H100, Cyber Ho 100, Litho 100	Quanta System Spa	2018-05-08	29	0
K180426	Empower H35	Quanta System Spa	2018-03-16	28	0
K180423	Empower H65	Quanta System Spa	2018-03-15	27	0
K180158	Surgical Laser fibers	Quanta System Spa	2018-02-14	26	0
K173002	2940 nm Er:Yag Laser Handpiece	Quanta System Spa	2017-12-13	77	0
K172376	Discovery Pico, Discovery Pico Plus	Quanta System Spa	2017-10-19	73	0
K172198	585	Quanta System Spa	2017-10-17	88	0
K172025	Litho 60	Quanta System Spa	2017-07-31	26	0
K171945	Discovery Pico, Discovery Pico Plus	Quanta System Spa	2017-07-28	30	0
K171711	Thunder, Thunder VT, Thunder HR	Quanta System Spa	2017-07-07	28	0
K170331	Cyber Ho	Quanta System Spa	2017-03-03	29	0
K163222	Discovery Pico Family	Quanta System Spa	2016-12-05	19	0
K163009	Litho	Quanta System Spa	2016-12-01	34	0
K160368	EVO platform	Quanta System Spa	2016-04-05	56	0
K160513	Quanta System Surgical Laser fibers	Quanta System Spa	2016-03-18	23	0
K152714	Quanta Forte	Quanta System Spa	2015-12-21	91	0
K152012	EVO platform	Quanta System Spa	2015-12-08	140	0
K151629	Guardian 1000	Quanta System Spa	2015-10-27	132	0
K152220	MH01	Quanta System Spa	2015-09-03	27	0
K141101	LITHO	Quanta System Spa	2014-08-08	101	0
K141403	LITHO DK30	Quanta System Spa	2014-08-07	71	0
K131473	(QUANTA SYSTEM) SURGICAL LASER FIBERS	Quanta System Spa	2013-10-24	155	0
K131081	CYBER TM FAMILY	Quanta System Spa	2013-07-03	76	0
K130256	MDK MULTI-APPLICATIONS PLATFORM	Quanta System Spa	2013-07-02	151	0
K123573	YOULASER CO2 LASER	Quanta System Spa	2013-04-15	146	0
K123168	Q-PLUS T+ IPL LASER SYSTEM	Quanta System Spa	2012-12-20	72	1
K111592	YOULASER CO2 LASER SYSTEM	Quanta System Spa	2011-08-25	79	0
K103539	QUANTA SYSTEM DUOLITE	Quanta System Spa	2011-01-20	49	0
K102749	QUANTA CYBER TM 150W	Quanta System Spa	2010-12-10	78	0
K100558	QUANTA DIODE LASER SYSTEM	Quanta System Spa	2010-07-22	143	0
K091909	LITHO LASER SYSTEM	Quanta System Spa	2009-07-09	14	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda