Strata Skin Sciences, Inc.

Carlsbad, CA, US

Strata Skin Sciences, inc. appears in FDA device records in Carlsbad, CA. FDA records list 2 510(k) clearances between 2018-08-01 and 2020-01-14, 12 PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 12
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Strata Skin Sciences, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

MELA Sciences, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Strata Skin Sciences, Inc. between 2018 and 2020. The busiest year on record is 2018, with 1. The most recent is 2020, with 1.

Clearances by year, as a table

510(k) clearance decisions for Strata Skin Sciences, Inc., by decision year
Year	Clearances
2018	1
2020	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K193478	XTRAC Momentum Excimer Laser System	GEX	Substantially Equivalent	2020-01-14
K181480	MMD Tip	GEX	Substantially Equivalent	2018-08-01

Registered establishments

FDA registered establishments for Strata Skin Sciences, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2031934	3002942014	Strata Skin Sciences, inc.	2375 Camino Vida Roble, Carlsbad, CA 92011 US	2026	GEX ONF

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1455-2017	XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.	When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing.	Class II	2017-01-23	Terminated
Z-1636-2015	MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.	The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).	Class II	2015-04-02	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain