FDA daily for Thursday, August 28, 2025
In this issue: 23 approvals, 1 device recall, 28 device decisions and 74 label changes. 3 items touch categories MedGrid carries, and they come first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
- IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
Shenzhen Mlay Intelligent Technology Co., , Ltd. · General, Plastic Surgery
- Sun Bum 70 Premium Moisturizing Sunscreen 8 OZ, Sun Bum 70 Premium Moisturizing Sunscreen 3 OZ
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · Sun Bum, LLC · TOPICAL
Drug and biologic approvals
FDA date:On Thu, Aug 21 FDA approved 2 new applications (1 brand or biologic, 1 generic) and 21 supplements to existing ones.
- NALOXONE HYDROCHLORIDE
STERINOVA INC · NALOXONE HYDROCHLORIDE
- DAWNZERA (AUTOINJECTOR)
IONIS PHARMS INC · DONIDALORSEN SODIUM
Device recalls
FDA date:FDA posted 1 device recall from 1 firm on Thu, Aug 21.
- OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vap…
LUMENIS, LTD. · The potential for unsterilized product within finished product labeled as sterile.
Device clearances and approvals
FDA date:FDA decided 11 510(k)s and 17 PMA decisions on Thu, Aug 14.
- IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
Shenzhen Mlay Intelligent Technology Co., , Ltd. · General, Plastic Surgery
- FilmArray GI Control Panel M238
Maine Molecular Quality Controls, Inc. · Microbiology
- mOm Essential Incubator (ME1)
Mom Incubators Limited · General Hospital
- BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
Biofire Diagnostics, LLC · Microbiology
- TRUDERMAL Pro (ZLD-390)
Shenzhen Kaiyan Medical Equipment Co., Ltd. · General, Plastic Surgery
- 3nethra neo HD FA; 3nethra neo HD
Forus Health Pvt.Ltd · Ophthalmic
- Cassette Autoclave (ACA5)
Guangzhou Ajax Medical Equipment Co., Ltd. · General Hospital
- WinForth (LM-E470KA)
Shenzhen Leaflife Technology Co., Ltd. · General, Plastic Surgery
- Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)
Stryker Sustainability Solutions · Unknown
- Stitch Cerclage Suture Tapes
GM Dos Reis Industria e Comercio Ltda. · Orthopedic
Label updates
FDA date:74 drug labels took effect on Thu, Aug 14; 17 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Sun Bum 70 Premium Moisturizing Sunscreen 8 OZ, Sun Bum 70 Premium Moisturizing Sunscreen 3 OZ
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · Sun Bum, LLC · TOPICAL
- Sun Bum 30 Premium Moisturizing Sunscreen
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · Sun Bum, LLC · TOPICAL
- Sun Bum 50 Premium Moisturizing Sunscreen, Sun Bum 50 Premium Moisturizing Sunscreen 8 OZ +1
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · Sun Bum, LLC · TOPICAL
- Sun Bum 15 Premium Moisturizing Sunscreen 8 OZ, Sun Bum 15 Premium Moisturizing Sunscreen 6 OZ
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · Sun Bum, LLC · TOPICAL
- Sun Bum 50 Mineral Sunscreen
ZINC OXIDE · Sun Bum, LLC · TOPICAL
- Sun Bum Kids 50 Clear Sunscreen Face Stick
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · Sun Bum, LLC · TOPICAL
- Sun Bum 50 Mineral Sunscreen
TITANIUM DIOXIDE, ZINC OXIDE · Sun Bum, LLC · TOPICAL
- Sun Bum 50 Mineral Sunscreen Roll-On
TITANIUM DIOXIDE, ZINC OXIDE · Sun Bum, LLC · TOPICAL
- Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Bonfire, Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Bonfire Carded
HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE · Sun Bum, LLC · TOPICAL
- Sun Bum 50 Premium Moisturizing Sunscreen
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · Sun Bum, LLC · TOPICAL
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
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